BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183513658
• Version / Model: BR08-94120
• Catalog Number: BR08-94120
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-17
• Public Version: 1
• Public Version Date: 2023-04-25
• Public Version Status: New
• Public Device Record Key: 70ea2b68-e43c-4ae0-ad68-1ef8c9f2eeeb

Device Description

Bandage and Plaster Shears, with rachet, wire cutter and serrated blade, 8"

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: ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRW	Scissors, General, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13481	Bandage scissors, reusable	A hand-held manual instrument intended to be used to cut bandages and cloth. Typically a robust instrument, it comprises two pivoted blades provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded for safety; one blade may extend in front of the other and have an olive tip that is placed under the bandage. It is typically made of high-grade stainless steel and some may use carbide inserts for the cutting edge. This is a reusable device.	No	Active
32885	Wire cutter	A heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183513658	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]