BIRMINGHAM HIP RESURFACING (BHR)

Basic Information

• Brand Name: BIRMINGHAM HIP RESURFACING (BHR)
• Primary DI: 00885556075937
• Version / Model: 90127730
• Catalog Number: 90127730
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-01
• Public Version: 5
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 16dc5644-b544-4455-859e-37f4db37a3e9

Device Description

BHR DEBRIS CAP 38MM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXT	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60942	Orthopaedic surgery tissue debris collector, reusable	A device intended to be fitted to an orthopaedic rotary cutting tool (e.g., reamer) to collect bone, cartilage, or adjacent soft tissue debris/fragments created through resection during orthopaedic surgery (e.g., hip resurfacing). It is typically in the form of a cup-shaped attachment intended to prevent particulate bone entering the surgical wound. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556075937	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P040033	015