714-S

GUDID 40653405014387

EPILATION/TELANGIECTASIAS NEEDLE STEALTH ER COATING 30 DEGREE ANGLE, 3/8" NEEDLE ELECTRODE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, reusable
Primary Device ID40653405014387
NIH Device Record Keybbe77330-a1f5-408f-affc-ac7320741666
Commercial Distribution StatusIn Commercial Distribution
Version Model Number714-S
Catalog Number714-S
Company DUNS071595540
Company NameConmed Corporation
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch
Angle30 degree
Outer Diameter0.375 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -34 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405014389 [Unit of Use]
GS120653405014383 [Package]
Contains: 30653405014380
Package: BOX [6 Units]
In Commercial Distribution
GS130653405014380 [Primary]
GS140653405014387 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


[40653405014387]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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30653405987592 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
30653405987608 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
30653405990141 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
20653405990120 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 23 x 25 mm
20653405990137 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 35 x 25 mm

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