Duns Number:017415781
Device Description: Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pe Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. One (1) tube of PSD Gel (Gel) is provided for every two (2) pouches of PSD-V. The Gel is used to create a temporary bond between the PSD-V buttress and the surgical stapler jaws until the stapler is positioned and fired.
Catalog Number
PSD4502ECHV
Brand Name
Peri-Strips Dry with Veritas Collagen Matrix
Version/Model Number
PSD4502ECHV
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2016
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
2ef7bb89-8048-4ee1-96f2-6ffcb1fdfc20
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 05, 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. | 135 |