Catalog Number

C-M112-7-500

Brand Name

System12

Version/Model Number

C-M112-7-500

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

K063550,K063550,K063550

Product Code

KWZ

Product Code Name

Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Public Device Record Key

0c647c84-7091-40ce-b2d5-d27b67a07bf4

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

37613327579797

Quantity per Package

1

Contains DI Package

07613327579802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack