BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183528416
• Version / Model: BR980-9101
• Catalog Number: BR980-9101
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-30
• Public Version: 1
• Public Version Date: 2024-11-07
• Public Version Status: New
• Public Device Record Key: 8e5ba72c-0049-4dd5-9dc6-2183394cd1f7

Device Description

Minor Balloon Sinus Kit, (5) per box: 4-ply 17" x 19" Towel/Drape, 10cc Control Syringe, Neuro Sponges 1/2" x 3" (10 Patties/Card), 2oz Medicine Cups (3 per pack), 25ga x 3 1/2" Spinal Needle, Half Shallow Tray, 24" x 24" Wrap, Sterilization Pouch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
44069	ENT surgical procedure kit, non-medicated, single-use	A collection of various sterile 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183528416	GS1

Customer Contacts

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