Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

3082-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2021

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

ef9740cf-2ab4-4599-be5d-ba4104239cc6

Public Version Date

March 01, 2021

Public Version Number

3

DI Record Publish Date

December 31, 2019

Package DI Number

58100013404813

Quantity per Package

36

Contains DI Package

18100013404822

Package Discontinue Date

February 28, 2021

Package Status

Not in Commercial Distribution

Package Type

Case