Catalog Number

-

Brand Name

ColActive Plus Powder Ag Wound Filler

Version/Model Number

10160002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K060804,K060804,K060804

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

55f57e5e-ed35-4ab8-8904-28bd22852023

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 27, 2021

Package DI Number

04052199578736

Quantity per Package

1

Contains DI Package

04052199578729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-