CONMED GOLDLINE 130318A

GUDID 00653405056303

CONMED GOLDLINE ELECTROSURGICAL HANDPIECE, BLADE ELECTRODE, BUTTON SWITCH, SAFETY HOLSTER, AND 10FT CABLE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID00653405056303
NIH Device Record Key301641ef-3c86-4fee-9453-3e9bfc474a0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONMED GOLDLINE
Version Model Number130318A
Catalog Number130318A
Company DUNS071595540
Company NameConmed Corporation
Device Count250
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 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(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

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 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 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405056303 [Unit of Use]
GS120653405056307 [Primary]
GS130653405056304 [Previous]

FDA Product Code

GEIElectrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-14
Device Publish Date2023-12-06

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