Catalog Number

607-004-812

Brand Name

PriMatrix®

Version/Model Number

607-004-812

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

K131286

Product Code

KGN

Product Code Name

DRESSING, WOUND, COLLAGEN

Public Device Record Key

d83904b3-f02f-44f7-bc90-47bd47e4005b

Public Version Date

October 04, 2022

Public Version Number

5

DI Record Publish Date

June 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-