Catalog Number

66800461

Brand Name

ALLEVYN AG GENTLE BORDER 10 X 10 CM

Version/Model Number

66800461

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K063835,K063835,K063835

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

a34c0981-7f29-413f-9e5c-4e15d772c75b

Public Version Date

July 08, 2020

Public Version Number

3

DI Record Publish Date

May 15, 2020

Package DI Number

05000223465995

Quantity per Package

10

Contains DI Package

05000223465988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton