Home GUDID 20653405008269
HAND-TROL GOLD LINE
Primary DI 20653405008269
Brand HAND-TROL GOLD LINE
Company Conmed Corporation
Model 60-0300-501
Catalog number 60-0300-501
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 true
OTC false
Sterile true
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 20653405008269 Package GS1 50 Not in Commercial Distribution 30653405008266 Primary GS1 0 00653405008265 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 20653405008269 20653405008269 30653405008266 30653405008266 00653405008265 00653405008265 653405008265 0653405008265
GMDN Terms# Term, Definition table Term Definition Open-surgery electrosurgical handpiece/electrode, monopolar, single-use A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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 -34 Degrees Celsius 65 Degrees Celsius Handling Environment Temperature -29 Degrees Fahrenheit 149 Degrees Fahrenheit Storage Environment Humidity 5 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 32 Degrees Celsius Storage Environment Temperature 50 Degrees Fahrenheit 90 Degrees Fahrenheit
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 071595540 Device count 50 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 false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes#