Catalog Number

-

Brand Name

Kastormed

Version/Model Number

5cm×5cm

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)

-

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

5c4407de-6090-47e6-af88-4022ecaa0d94

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Package DI Number

26958868742120

Quantity per Package

10

Contains DI Package

16958868742123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box