Duns Number:796253292
Device Description: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterileand is provi PriMatrix is an acellular dermal tissue matrix. The device is supplied sterileand is provided in sheet form in a variety of sizes to be trimmed by thesurgeon to meet the individual patient's needs.
Catalog Number
6495-9-118
Brand Name
PriMatrix®
Version/Model Number
6495-9-118
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
c836d0ca-8f1b-4c36-bc53-b6f2afb03ebd
Public Version Date
October 02, 2020
Public Version Number
5
DI Record Publish Date
October 21, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 81 |
| U | Unclassified | 55 |