Catalog Number

9CC0.13.03D

Brand Name

ProMade

Version/Model Number

9CC0.13.03D

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

-

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

K112158

Product Code

JDI

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Public Device Record Key

8254e5c9-e23a-4009-a8ae-539b5d2beccd

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-