Duns Number:017415781
Device Description: Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) Circular Staple Line Reinforcement is Peri-Strips Dry with Veritas Collagen Matrix (PSD-V) Circular Staple Line Reinforcement is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The packaging contains two loading units w/buttress material, one for the anvil and one for the cartridge side of the stapler. The packaging also includes one cartridge cone to aid atraumatic advancement of the stapler into the surgical site, and one tube of PSD Gel to create a temporary bond between the buttress and the surgical stapler until the stapler is positioned and fired.
Catalog Number
PSD21EVBIO
Brand Name
Peri-Strips Dry with Veritas Collagen Matrix Circular
Version/Model Number
PSD21EV
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
0bc32dc8-6e36-44fc-9b93-ae5f6545f0be
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 |