Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

EP90529XXLPB-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 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

ba9e1dc5-2105-441c-8392-3322a4c0edf1

Public Version Date

August 18, 2021

Public Version Number

2

DI Record Publish Date

December 31, 2019

Package DI Number

58100013411552

Quantity per Package

6

Contains DI Package

18100013411561

Package Discontinue Date

August 17, 2021

Package Status

Not in Commercial Distribution

Package Type

Case