60-5160-004

GUDID 20653405034787

Laparoscopic Electrode with 4mm Pin and Disposable Cord

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID20653405034787
NIH Device Record Key66be2b01-b37d-4dc9-9486-c7a1d8235a9d
Commercial Distribution Discontinuation2016-12-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number60-5160-004
Catalog Number60-5160-004
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

Device Dimensions

Length32 Centimeter
Outer Diameter5 Millimeter
Length32 Centimeter
Outer Diameter5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405034783 [Unit of Use]
GS120653405034787 [Package]
Contains: 30653405034784
Package: BOX [5 Units]
Discontinued: 2016-12-31
Not in Commercial Distribution
GS130653405034784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HFGCOAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20653405034787]

Ethylene Oxide


[20653405034787]

Ethylene Oxide


Device Entry Metadata

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

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