Catalog Number

1722-0-3256

Brand Name

CS2 Acet. Cup Sys. - VitalitE

Version/Model Number

1722-0-3256

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OQG

Product Code Name

Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Public Device Record Key

4971d73f-4ae4-4037-a688-417f97f6e2b7

Public Version Date

March 07, 2022

Public Version Number

2

DI Record Publish Date

January 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-