Catalog Number

-

Brand Name

Aladerm Plus

Version/Model Number

282

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K141637

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

c1582baf-e5dd-436d-8bcc-c113e65a8efd

Public Version Date

February 17, 2022

Public Version Number

1

DI Record Publish Date

February 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-