HAND-TROL GOLD LINE 60-0300-002

GUDID 10653405008255

HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID10653405008255
NIH Device Record Keyca8fd264-824b-44b7-a328-0fabbbee63a5
Commercial Distribution Discontinuation2017-07-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHAND-TROL GOLD LINE
Version Model Number60-0300-002
Catalog Number60-0300-002
Company DUNS071595540
Company NameConmed Corporation
Device Count100
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 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

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100653405008258 [Unit of Use]
GS110653405008255 [Package]
Contains: 20653405008252
Package: BOX [100 Units]
Discontinued: 2017-07-05
Not in Commercial Distribution
GS120653405008252 [Primary]

FDA Product Code

DWGELECTROSURGICAL DEVICE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2016-09-24

On-Brand Devices [HAND-TROL GOLD LINE]

20653405008269HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE
10653405008255HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE
20653405008276HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.