Duns Number:796253292
Device Description: PriMatrix Ag Antimicrobial is an acellular dermal tissue matrix derived from fetal bovine PriMatrix Ag Antimicrobial is an acellular dermal tissue matrix derived from fetal bovine dermis. PriMatrix Ag Antimicrobial is supplied sterile in a variety of sizes that can be trimmed by the surgeon to meet the individual patient's needs. The Ionic Silver content is intended to prevent microbial colonization of the device.
Catalog Number
607-105-440
Brand Name
PriMatrix Ag
Version/Model Number
607-105-440
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K100261
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
177151dc-5f5b-4cd1-9cd2-f6f0fedf534e
Public Version Date
October 02, 2020
Public Version Number
5
DI Record Publish Date
October 14, 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 |