Catalog Number

GMH02-100004

Brand Name

Initia Total Hip System

Version/Model Number

GMH02-100004

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

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

LPH

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Public Device Record Key

9c9c609d-c37a-4116-9723-550a4893915b

Public Version Date

May 21, 2020

Public Version Number

4

DI Record Publish Date

February 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-