gSource

Basic Information

• Brand Name: gSource
• Primary DI: 00840314238184
• Version / Model: gS 73.2838
• Catalog Number: gS 73.2838
• Company Name: GSOURCE LLC
• Labeler DUNS: 008162518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-24
• Public Version: 2
• Public Version Date: 2022-10-03
• Public Version Status: Update
• Public Device Record Key: 91990860-f6ff-4367-b6e9-0dbf9bfec761

Device Description

Wolff Plaster Cast Breaker 7"

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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46313	Cast breaker	A manual surgical instrument with strong, curved blades used to grasp and break apart hardened plaster, i.e., that which has already been used to form a cast around a patient's limb or body part. It is designed like a large size forceps with curved serrated (serrated on the inside to provide grip) blades. These blades are prised between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create a grip on the plaster that can then be broken off in pieces. It is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840314238184	GS1