Catalog Number

-

Brand Name

E.M. Adams Co, Inc.

Version/Model Number

EP40407XL-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

fe5c4534-7e69-4f0d-87b9-c1711f55c739

Public Version Date

May 18, 2022

Public Version Number

1

DI Record Publish Date

May 10, 2022

Package DI Number

50840200325290

Quantity per Package

24

Contains DI Package

10840200325308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case