Catalog Number

479.248B

Brand Name

Cormet

Version/Model Number

479.248B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2014

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

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

P050016

Product Code

NXT

Product Code Name

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

Public Device Record Key

18cc3f1c-a33e-41f9-b386-07cb53e6d8fa

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

October 14, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-