Home GUDID 10653405008255
HAND-TROL GOLD LINE
Primary DI 10653405008255
Brand HAND-TROL GOLD LINE
Company Conmed Corporation
Model 60-0300-002
Catalog number 60-0300-002
Device description HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name DWG ELECTROSURGICAL DEVICE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWG Electrosurgical Device General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10653405008255 Package GS1 100 Not in Commercial Distribution 20653405008252 Primary GS1 0 00653405008258 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10653405008255 10653405008255 20653405008252 20653405008252 00653405008258 00653405008258 653405008258 0653405008258
GMDN Terms# Term, Definition table Term Definition Open-surgery electrosurgical electrode, monopolar, single-use An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 0 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature -29 Degrees Celsius 50 Degrees Celsius Handling Environment Temperature -20 Degrees Fahrenheit 120 Degrees Fahrenheit Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 32 Degrees Celsius Storage Environment Temperature 50 Degrees Fahrenheit 90 Degrees Fahrenheit
Regulatory Flags# DUNS number 071595540 Device count 100 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#