gSource

Basic Information

• Brand Name: gSource
• Primary DI: 00840314243454
• Version / Model: gS 82.4100
• Catalog Number: gS 82.4100
• Company Name: GSOURCE LLC
• Labeler DUNS: 008162518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-27
• Public Version: 3
• Public Version Date: 2022-08-19
• Public Version Status: Update
• Public Device Record Key: 3f9b309a-8a43-489c-bb47-12690f208c3a

Device Description

Wire Tightener 4 3/4"

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
HXP	Instrument, Bending Or Contouring	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32881	Wire twister	A surgical instrument specifically designed to twist surgical wire after this has been applied to the site in order to tighten the loop or binding that has been made by the surgeon. The loose ends of the wire are inserted into and gripped by the jaws of this device, and the surgeon pulls a handle which spins the spirally grooved centre piece, thereby twisting and tightening the wire. It is typically used in orthopaedic procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840314243454	GS1