Duns Number:796253292
Device Description: PriMatrix® is an acellular dermal tissue matrix derived from fetal bovine dermis. The devi PriMatrix® is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient’s needs.
Catalog Number
607-005-018
Brand Name
PriMatrix®
Version/Model Number
607-005-018
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
-
Product Code
KGN
Product Code Name
DRESSING, WOUND, COLLAGEN
Public Device Record Key
4525af0c-bc44-4c31-9ad9-35b4d361cbba
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
September 11, 2017
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 |