Catalog Number

8886834100

Brand Name

Dermacea

Version/Model Number

8886834100

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)

Yes

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

aabdf501-b03d-45f8-bc19-48f055eabdc8

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

June 27, 2018

Package DI Number

10884521065284

Quantity per Package

36

Contains DI Package

30884521065288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK