Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

EP90570XXL-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

-

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

K971948,K971948

Product Code

FMQ

Product Code Name

Restraint, Protective

Public Device Record Key

497b6d10-e286-450c-a049-4b13cdfe0167

Public Version Date

March 01, 2021

Public Version Number

3

DI Record Publish Date

December 31, 2019

Package DI Number

58100013411651

Quantity per Package

6

Contains DI Package

18100013411660

Package Discontinue Date

February 28, 2021

Package Status

Not in Commercial Distribution

Package Type

Case