BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183520403
• Version / Model: BR66-22012
• Catalog Number: BR66-22012
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-01
• Public Version: 1
• Public Version Date: 2024-02-09
• Public Version Status: New
• Public Device Record Key: c969ca64-c5fc-443d-b559-9932675bc94b

Device Description

JEWETT Urethral Sound, straight, Ø 12FR., 9 1/2"

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
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	876.5520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13643	Urethral sound, reusable	A hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183520403	GS1

Customer Contacts

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