Catalog Number

101-20-068

Brand Name

MANZA HA NON-CEMENTED CUP

Version/Model Number

101-20-068

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

K153131

Product Code

KWZ

Product Code Name

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Public Device Record Key

92307c78-6514-4f5b-bf0e-75500ac5924f

Public Version Date

September 09, 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

-