Catalog Number

DUP88512

Brand Name

ALGICELL® Ag

Version/Model Number

88512

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K080497,K080497

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

40b7ebb0-83b5-43ac-8107-dee8a165a886

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

October 23, 2018

Package DI Number

30381780491648

Quantity per Package

4

Contains DI Package

10381780491644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case