gSource

Basic Information

• Brand Name: gSource
• Primary DI: 00840314248053
• Version / Model: gS 99.9943
• Catalog Number: gS 99.9943
• Company Name: GSOURCE LLC
• Labeler DUNS: 008162518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-15
• Public Version: 2
• Public Version Date: 2022-09-27
• Public Version Status: Update
• Public Device Record Key: 9c7edd06-1ba6-4718-854c-d60cbca31eb0

Device Description

Instrument Container Identification Tag, 56x17mm, blue, alum

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
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64816	Endodontic instrument identification tag	A label or a tag intended to be used to facilitate clear and easy identification of endodontic instruments (e.g., files/rasps) before or during a procedure (e.g., clinical, sterilization). It is typically colour-coded, with a writing surface, and with a hook or spike for insertion in a spongy foam insert that holds the instruments. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840314248053	GS1