Duns Number:372587696
Device Description: Polypropylene Nonabsorbable Synthetic Surgical Mesh
Catalog Number
PVPS
Brand Name
PROCEED
Version/Model Number
PVPS
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
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
da04ca57-5c65-48b1-9e5a-dd3b0cc6519d
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 01, 2015
Package DI Number
20705031132419
Quantity per Package
2
Contains DI Package
10705031132412
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 84 |