Catalog Number

441107

Brand Name

Dermacea

Version/Model Number

441107

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

1a63105f-0224-4e40-b5ad-1e6459bda811

Public Version Date

August 24, 2021

Public Version Number

4

DI Record Publish Date

June 29, 2018

Package DI Number

20884527021175

Quantity per Package

96

Contains DI Package

10884527021178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE