Catalog Number

-

Brand Name

Surpass Acetabular system

Version/Model Number

SC2603-28MM -3.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 14, 2016

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

-

Product Code

MRA

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Public Device Record Key

d86da78a-f41b-425b-9a78-6dd220ff8cb2

Public Version Date

December 11, 2020

Public Version Number

4

DI Record Publish Date

November 21, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-