Catalog Number

66021306, 66801306

Brand Name

Allevyn Life

Version/Model Number

66021306

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

74484ac8-ee97-4afc-953a-94ecb431554f

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

January 24, 2020

Package DI Number

05000223490539

Quantity per Package

6

Contains DI Package

05000223490522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case