Catalog Number

NC089K

Brand Name

Metha®

Version/Model Number

NC089K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 27, 2017

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

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

-

Product Code

LWJ

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Public Device Record Key

50773828-e353-4a52-a2d8-9467e708646b

Public Version Date

June 28, 2018

Public Version Number

3

DI Record Publish Date

July 27, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-