Duns Number:017415781
Device Description: PSD Gel is prepared from Hydroxypropyl Methyl Cellulose, Propylene Glycol, and water. The PSD Gel is prepared from Hydroxypropyl Methyl Cellulose, Propylene Glycol, and water. The PSD Gel is used to bond the Peri-Strips Dry pericardium strips onto the surgical stapler forks until the stapler is positioned and fired.
Catalog Number
PSDGel3pkwTips
Brand Name
PSD gel
Version/Model Number
PSDGEL3PKWTIPS
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
a8cecb0e-4f69-43d8-901f-c5a34c7cd245
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
October 05, 2015
Package DI Number
50085412531439
Quantity per Package
3
Contains DI Package
00085412531434
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 |