Catalog Number

-

Brand Name

Tex-Care Medical

Version/Model Number

91319-225

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IPM

Product Code Name

Cover, Limb

Public Device Record Key

8f93483b-a141-4ceb-b89c-d57e2bf06cf3

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Package DI Number

30632195001985

Quantity per Package

12

Contains DI Package

00632195001984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-