Catalog Number

-

Brand Name

E.M. Adams Co, Inc.

Version/Model Number

EP90401XXL-1

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

-

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

a5f7a9db-fc4a-425d-aa22-9ba4a549e79b

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

50840200323555

Quantity per Package

6

Contains DI Package

10840200323564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case