Catalog Number

-

Brand Name

Algitocare alginate wound dressing

Version/Model Number

AF04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 01, 2027

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

e25c193d-11e0-4745-b6ba-6515be78867b

Public Version Date

September 20, 2022

Public Version Number

2

DI Record Publish Date

August 02, 2022

Package DI Number

16934889085159

Quantity per Package

5

Contains DI Package

06934889085152

Package Discontinue Date

August 01, 2027

Package Status

In Commercial Distribution

Package Type

-