BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183512941
• Version / Model: BR980-9105
• Catalog Number: BR980-9105
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-23
• Public Version: 1
• Public Version Date: 2024-07-31
• Public Version Status: New
• Public Device Record Key: c84a1c22-5c84-440a-a8cd-c518992526db

Device Description

Myringotomy Kit, (5) per box, consisting of Ear Tube (Pope), Ear Tube (T Tube), Myringotomy Blade, Plastic Ear Speculum 4mm and 6mm, Gauze 4x4 12 ply (2), Large Cotton Ball (2), 2-Compartment Tray, CSR 20x20 Wrap, 10x15 Peel 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
OGS	Myringotomy Procedure Kit	Ear, Nose, Throat	874.3880	2

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	00840183512941	GS1

Customer Contacts

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