Catalog Number

MH71097

Brand Name

Uni-Patch

Version/Model Number

MH71097

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

-

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

IME

Product Code Name

Pack, hot or cold, reuseable

Public Device Record Key

b8c55aab-b646-42b9-a5b9-36115f866069

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884527022424

Quantity per Package

12

Contains DI Package

10884527022427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE