Catalog Number

30955689

Brand Name

Kendall

Version/Model Number

30955689

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

de461ed6-3288-4e6d-b165-06cb4411a0d8

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

10884527005383

Quantity per Package

50

Contains DI Package

20884527005380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE