Catalog Number

55535P

Brand Name

Kendall

Version/Model Number

55535P

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

NAD

Product Code Name

Dressing, wound, occlusive

Public Device Record Key

41bedd10-4237-4880-8e2d-56a7b2e66e9f

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

June 27, 2018

Package DI Number

00884521020880

Quantity per Package

50

Contains DI Package

00884521003654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE