BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183502072
• Version / Model: BR900-5050-ACMI
• Catalog Number: BR900-5050-ACMI
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-22
• Public Version: 1
• Public Version Date: 2024-07-30
• Public Version Status: New
• Public Device Record Key: cf487926-6958-4ab5-8c19-c90cdd6c7c71

Device Description

Fiber Light Cable, standard, ACMI/ACMI (Scope/Source) fitting, 3.5mm x 10 ft.

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, Ethylene Oxide, Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	874.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35507	Fibreoptic light cable	A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183502072	GS1

Customer Contacts

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