Catalog Number

30975232

Brand Name

Kendall

Version/Model Number

30975232

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

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

fc5556e9-924a-45ce-88b8-576c40671fb6

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

June 23, 2018

Package DI Number

10884527005406

Quantity per Package

50

Contains DI Package

20884527005403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE