gSource

Basic Information

• Brand Name: gSource
• Primary DI: 00840314223890
• Version / Model: gS 50.6110
• Catalog Number: gS 50.6110
• Company Name: GSOURCE LLC
• Labeler DUNS: 008162518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-13
• Public Version: 2
• Public Version Date: 2022-08-17
• Public Version Status: Update
• Public Device Record Key: 9c311f96-5bf8-4f7b-bca6-ad0c731b9603

Device Description

Keyes Punch 4" 2mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRY	Punch, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35289	Skin-coring punch, reusable	A hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically metallic and is available in various cutting head sizes; it is not a biopsy gun. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840314223890	GS1