Catalog Number

IMX-0406-01

Brand Name

InnovaMatrix AC

Version/Model Number

IMX-0406-01

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)

Yes

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

K193552

Product Code

KGN

Product Code Name

Dressing, Wound, Collagen

Public Device Record Key

b5c93800-2a58-4013-a1fa-530d0c2d302b

Public Version Date

January 05, 2022

Public Version Number

1

DI Record Publish Date

December 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-