60-5163-004

GUDID 20653405034442

Laparoscopic Electrode with 4mm Pin and Disposable Cord

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID20653405034442
NIH Device Record Keya37760be-1797-4efe-8910-ed4aae47243e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number60-5163-004
Catalog Number60-5163-004
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com

Device Dimensions

Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
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 Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
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 Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 16 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 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 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405034448 [Unit of Use]
GS120653405034442 [Package]
Contains: 30653405034449
Package: BOX [5 Units]
In Commercial Distribution
GS130653405034449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HFGCOAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


[20653405034442]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-09-24

Devices Manufactured by Conmed Corporation

30653405987585 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
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
20653405990144 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 40 x 60 mm
20653405990151 - BioBrace2024-09-30 BioBrace® Reinforced Implant, Foot & Ankle, 40 x 60 mm

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