Catalog Number

WB-1-1119

Brand Name

Microseal Augmented 20 Degree Liner

Version/Model Number

26x52x20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K955271

Product Code

LPH

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Public Device Record Key

9d5d1330-df2e-425a-b46c-d13ae007963a

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

April 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-