Catalog Number

66802138

Brand Name

ALLEVYN GENTLE 15cmx15cm CTN 5-DE

Version/Model Number

66802138

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

b08ffa9c-47f3-4d66-a700-fe0a220c6543

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

May 15, 2020

Package DI Number

05000223495176

Quantity per Package

5

Contains DI Package

05000223495107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton