Catalog Number

40000008

Brand Name

Kendall

Version/Model Number

40000008

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"

-

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

b7643e6c-14ab-4c00-819f-98ced0d397a7

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

10884527005529

Quantity per Package

50

Contains DI Package

20884527005526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE