Catalog Number

66801082

Brand Name

REN/ASYS ADHESIVE GEL PATCH

Version/Model Number

66801082

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

cd3562cc-ac09-4274-95cc-63af6522ad72

Public Version Date

October 12, 2020

Public Version Number

1

DI Record Publish Date

October 02, 2020

Package DI Number

00040565125961

Quantity per Package

10

Contains DI Package

00040565125954

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton