Catalog Number

-

Brand Name

ColActive Plus Powder Wound Filler

Version/Model Number

10160001

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

69b2222d-83c4-4208-8c11-f89ba570a813

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 27, 2021

Package DI Number

04052199578767

Quantity per Package

1

Contains DI Package

04052199578750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-