Catalog Number

442300

Brand Name

Dermacea

Version/Model Number

442300

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

775e9bb0-4c4f-495c-b285-1cc6a8bb8c9a

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 29, 2018

Package DI Number

40884521143808

Quantity per Package

800

Contains DI Package

30884521143801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE