Catalog Number

441501

Brand Name

Dermacea

Version/Model Number

441501

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

FQM

Product Code Name

BANDAGE, ELASTIC

Public Device Record Key

8b74f2ca-83c3-4fd7-a152-e27ad5c5d61a

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Package DI Number

20884527008763

Quantity per Package

96

Contains DI Package

10884527008766

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE