Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

EP9038-1

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

FSD

Product Code Name

Binder, Abdominal

Public Device Record Key

fbafc8f0-ab01-4a58-b361-cb9e2d2684f1

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

Package DI Number

50840200310395

Quantity per Package

24

Contains DI Package

10840200310403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case