Duns Number:343337499
Device Description: Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal ti Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue that has been processed and terminally sterilized via gamma irradiation. The surgical mesh device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with patient’s tissue. The sterile device is supplied pre-hydrated in water and is provided in various sizes. The device is ready for immediate use without extra preparation (i.e., no rinsing, no s
Catalog Number
PD1025
Brand Name
Fortiva™ Porcine Dermis
Version/Model Number
PD1025
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
FTM
Product Code Name
Mesh, surgical
Public Device Record Key
36dabca5-b0e8-4aaa-9988-eeaca4b5dd52
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 24, 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. | 31 |