Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

81611

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"

Yes

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

FMP

Product Code Name

Protector, skin pressure

Public Device Record Key

c24633e8-9ad1-45b2-acdb-49434a6b9028

Public Version Date

February 18, 2021

Public Version Number

1

DI Record Publish Date

February 10, 2021

Package DI Number

20809160345280

Quantity per Package

20

Contains DI Package

10809160345283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-