Catalog Number

-

Brand Name

HLS UNI EVOLUTION

Version/Model Number

GDU124

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2017

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

-

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

-

FDA Premarket Submission

K022211

Product Code

HSX

Product Code Name

PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Public Device Record Key

1fa40ac9-552b-4325-8a65-138095dd98d9

Public Version Date

October 03, 2018

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-