700

GUDID 10653405014218

REUSABLE ELECTRODE KIT FOR USE WITH HYFRECATOR

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, reusable
Primary Device ID10653405014218
NIH Device Record Key7eb16bf2-1f73-4e10-9d15-06081f26cbe8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number700
Catalog Number700
Company DUNS071595540
Company NameConmed Corporation
Device Count5
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405014211 [Unit of Use]
GS110653405014218 [Direct Marking]
GS120653405014215 [Primary]
GS130653405014212 [Package]
Contains: 20653405014215
Package: POUCH [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

Moist Heat or Steam Sterilization


[10653405014218]

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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