Duns Number:017415781
Device Description: PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 month PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe
Catalog Number
PSDA60GIA
Brand Name
PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP
Version/Model Number
PSDA60GIA
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
K213125,K213125
Product Code
FTM
Product Code Name
Mesh, surgical
Public Device Record Key
22ae4ac4-df5e-4e3b-ade3-e25bd488f107
Public Version Date
October 11, 2022
Public Version Number
2
DI Record Publish Date
December 01, 2021
Package DI Number
50085412658785
Quantity per Package
6
Contains DI Package
00085412658780
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |