BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183513498
• Version / Model: BR26-11124
• Catalog Number: BR26-11124
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-28
• Public Version: 1
• Public Version Date: 2022-12-06
• Public Version Status: New
• Public Device Record Key: 2e2529c4-259d-4a5a-8769-28f42d14f06c

Device Description

DESCHAMPS Ligature Needle, sharp, right, 9-1/2"

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
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63597	Ligature loop applier	A hand-held manual surgical instrument designed for the application of a ligature loop (e.g., wire, suture, tubing) around a blood vessel, or other tissue, for occlusion during open surgery. It is typically a slender rod with a hook at the distal end; it does not include a ligature passing mechanism (i.e., not a passer). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183513498	GS1

Customer Contacts

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