gSource

Basic Information

• Brand Name: gSource
• Primary DI: 00840314200785
• Version / Model: gS 12.4000
• Catalog Number: gS 12.4000
• Company Name: GSOURCE LLC
• Labeler DUNS: 008162518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-10
• Public Version: 2
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: b98b4eaf-c52a-40ed-a8fa-ca9e3f28076f

Device Description

Ulrich Fistula Knife 9", str

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
EMF	Knife, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35782	Tracheal bistoury	A surgical instrument in the form of a long, narrow-bladed knife designed for opening abscesses or slitting up sinuses and/or fistulas in the trachea. It is typically made of high-grade stainless steel and has a straight or curved cutting edge that terminates at the distal end with a sharp or blunt point. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840314200785	GS1