Catalog Number

-

Brand Name

Algitocare alginate wound dressing

Version/Model Number

AD10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 03, 2022

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

03733cda-2890-43f4-9781-18d7ab3f2ffe

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Package DI Number

16934889085036

Quantity per Package

10

Contains DI Package

06934889085039

Package Discontinue Date

July 12, 2022

Package Status

Not in Commercial Distribution

Package Type

-