Catalog Number

103-50-057

Brand Name

MANZA HEADS

Version/Model Number

103-50-057

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

K143184

Product Code

KWL

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal

Public Device Record Key

6fb1fe42-fa42-4927-b583-14e2427e9848

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

December 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-