Duns Number:097664937
Device Description: The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropyl The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall, leaving them lying in tissue tunnels created by the passer. The straps hold the body of the mesh in place.
Catalog Number
FVHR35X45
Brand Name
Freedom - Ventral Hernia Repair System
Version/Model Number
FVHR35X45
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"
Yes
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
K142192,K142192,K142192
Product Code
OXJ
Product Code Name
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
Public Device Record Key
851dc336-94fd-499e-8b93-8f3d73b6cc1f
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
July 22, 2015
Package DI Number
00013964672008
Quantity per Package
5
Contains DI Package
00850012832348
Package Discontinue Date
July 14, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |