BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183507237
• Version / Model: BR06-13000
• Catalog Number: BR06-13000
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-29
• Public Version: 1
• Public Version Date: 2023-04-06
• Public Version Status: New
• Public Device Record Key: 77c8e9a4-8e1d-4583-b514-a53e5750a036

Device Description

Surgical Blade Remover, removes blades from handles, protects hands

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

GMDN Terms

Code	Name	Definition	Implantable	Status
46235	Scalpel blade remover	A non-powered device intended to be used to safely remove and contain scalpel blades from reusable scalpel handles after use. It is typically a sealed container into which a scalpel is pushed, whereby an internal mechanism detaches the blade from the handle; the blade is retained within the container. This device may be used in a clinical or laboratory setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183507237	GS1

Customer Contacts

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