OrthoMedFlex - Femoral Head, SIZE 28mm, (XXL) CoCr Alloy - ORTHOMEDFLEX LLC

Duns Number:034442726

Device Description: Femoral Head, SIZE 28mm, (XXL) CoCr Alloy

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More Product Details

Catalog Number

AH1-528

Brand Name

OrthoMedFlex

Version/Model Number

AH1-528

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LPH

Product Code Name

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

Device Record Status

Public Device Record Key

0c6a9e47-7931-447c-aa98-90ebe484ceb7

Public Version Date

April 06, 2020

Public Version Number

3

DI Record Publish Date

October 09, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOMEDFLEX LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 371
2 A medical device with a moderate to high risk that requires special controls. 435