Catalog Number

40000008B

Brand Name

Kendall

Version/Model Number

40000008B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

ddf740c8-29ff-4da6-b18c-17a602facf23

Public Version Date

May 10, 2022

Public Version Number

4

DI Record Publish Date

June 27, 2018

Package DI Number

20884521133911

Quantity per Package

50

Contains DI Package

10884521133914

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE