BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183527723
• Version / Model: BR46-90000
• Catalog Number: BR46-90000
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-09
• Public Version: 1
• Public Version Date: 2024-08-19
• Public Version Status: New
• Public Device Record Key: 5eebe6dd-e3e4-44ae-8c7f-063843a9e24c

Device Description

Office Balloon Sinus Set, includes: Vienna Speculum, Bayonet fcp, Frontal Seeker, Maxillary Seeker, Freer elevator, Hartman-Noyes fcp, Frazier suct tube 5fr & 7fr, Filter, Paper Sterilization Indicators, and Sterilization tray w/mat 12"x5 1/2"x3"

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Ethylene Oxide, Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGR	Ear, Nose, And Throat Surgical Tray	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44067	ENT surgical procedure kit, non-medicated, reusable	A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183527723	GS1

Customer Contacts

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