Catalog Number

90129265

Brand Name

BIRMINGHAM HIP RESURFACING (BHR)

Version/Model Number

90129265

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P040033

Product Code

NXT

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Public Device Record Key

681b9a7a-5a2b-4b71-b9d3-5a1f32cb7b9a

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

May 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-