AccessGUDID - DEVICE: BIRMINGHAM HIP RESURFACING (BHR) (03596010502797)

GUDID

Device Identifier (DI) Information

Brand Name: BIRMINGHAM HIP RESURFACING (BHR)
Version or Model: 74121150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 74121150
Company Name: Smith & Nephew, Inc.

Primary DI Number: 03596010502797
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: RESURFACING FEMORAL HEAD 50MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33695	Bipolar femoral head outer component, hemiarthroplasty	An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NXT	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P040033	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1a740823-dc7c-4577-b6a3-9be4334d08d0
Public Version Date: September 07, 2023
Public Version Number: 5
DI Record Publish Date: May 01, 2015