BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183523008
• Version / Model: BR66-17508
• Catalog Number: BR66-17508
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-10
• Public Version: 1
• Public Version Date: 2024-06-18
• Public Version Status: New
• Public Device Record Key: 29f588bd-c263-48c5-92e4-834e53c2469b

Device Description

STOCKMANN Penile Clamp, 3"

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
FHA	Clamp, Penile	Gastroenterology, Urology	876.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10908	Surgical penile clamp	A manual surgical instrument with two blades that are joined at their midpoint, or made of a single alpha-shaped part, intended to stop blood flow to the penis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183523008	GS1

Customer Contacts

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