Catalog Number

66800453

Brand Name

ALLEVYN Ag Gentle Border 12.5cm x 12.5cm

Version/Model Number

66800453

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

f0151a2d-19c3-4f42-81ce-c7e70a2f3461

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

July 04, 2019

Package DI Number

05000223465902

Quantity per Package

10

Contains DI Package

05000223465896

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton