Catalog Number

-

Brand Name

ColActive Plus 2x2

Version/Model Number

10160000

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)

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

b1187956-9f0c-4046-8f03-12554308aac0

Public Version Date

August 16, 2021

Public Version Number

3

DI Record Publish Date

September 01, 2020

Package DI Number

00825439010020

Quantity per Package

10

Contains DI Package

00825439010013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-