HELIXAR 60-8480-001

GUDID 20653405001970

HELIXAR WIRELESS FOOTSWITCH KIT

Conmed Corporation

Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system
Primary Device ID20653405001970
NIH Device Record Key6a3730ab-ff1c-4baf-a730-df99a71b6424
Commercial Distribution Discontinuation2018-03-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHELIXAR
Version Model Number60-8480-001
Catalog Number60-8480-001
Company DUNS071595540
Company NameConmed Corporation
Device Count1
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 Perscriptionfalse
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween -29 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 20 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 38 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405001976 [Primary]
GS120653405001970 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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