Catalog Number

442214

Brand Name

Dermacea

Version/Model Number

442214

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

62f0e13f-8f63-45be-9cab-e7228a657f68

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

20884527021090

Quantity per Package

1280

Contains DI Package

10884527021093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE