Catalog Number

-

Brand Name

Abdominal Binder

Version/Model Number

4374

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ISR

Product Code Name

Band Or Belt, Pelvic Support

Public Device Record Key

37a9df47-f428-4932-8317-8a8e97a1a9ec

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Package DI Number

00616784437439

Quantity per Package

10

Contains DI Package

00616784437422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case