Catalog Number

441200

Brand Name

Dermacea

Version/Model Number

441200

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

573bfd52-d199-4610-8013-01eb6b1d7f49

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

20884521174877

Quantity per Package

480

Contains DI Package

10884521174870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE