Catalog Number

66020408, 66800835

Brand Name

ALLEVYN Gentle Border Lite 10cm x 10cm

Version/Model Number

66020408

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

a0c40221-be70-4f73-a9b3-502751668a5e

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

July 04, 2019

Package DI Number

05000223482985

Quantity per Package

10

Contains DI Package

05000223475499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton