Catalog Number

441214

Brand Name

Dermacea

Version/Model Number

441214

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

FRL

Product Code Name

FIBER, MEDICAL, ABSORBENT

Public Device Record Key

27773203-8c71-47ad-b6ff-6a4be1627dab

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

20884521066066

Quantity per Package

4000

Contains DI Package

10884521066069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE