Catalog Number

-

Brand Name

World 20° Hooded Liner Size 28A

Version/Model Number

111-49-1246

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

K201278

Product Code

KWZ

Product Code Name

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Public Device Record Key

5b62f8bd-a09a-4f8e-b3ef-f7f28c739762

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-