Duns Number:801160037
Device Description: Multi-purpose implantable surgical mesh, collagen, bioabsorbable-for use in procedures suc Multi-purpose implantable surgical mesh, collagen, bioabsorbable-for use in procedures such as achilles repair, rotator cuff and ligaments.
Catalog Number
PR-04074
Brand Name
Proformix
Version/Model Number
PR-0407
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
9a6105e6-1d4e-437e-bb7f-0a267dbca10f
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
April 01, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 3 |