ProDentUSA

Basic Information

• Brand Name: ProDentUSA
• Primary DI: 00810097676947
• Version / Model: GS12-00500
• Company Name: Professional Surgical Instruments Co., Inc.
• Labeler DUNS: 197354343
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-17
• Public Version: 1
• Public Version Date: 2026-02-25
• Public Version Status: New
• Public Device Record Key: b383cf40-2c16-4d70-84d5-8a457d5d0c09

Device Description

Goldman Fox Scissors 5" Straight, German Stainless Steel, 1 Serrated Blade

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: No
• 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
LRW	Scissors, General, Surgical	General, Plastic Surgery	878.4800	1
EGN	Scissors, Surgical Tissue, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31822	Dental surgical scissors	A hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.	No	Active
38727	General-purpose surgical scissors, reusable	A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810097676947	GS1