Duns Number:594540572
Device Description: OviTex™ Core Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaf OviTex™ Core Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). OviTex will incorporate into the recipient tissue with associated cellular and microvascular ingrowth.OviTex is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient’s requirements.
Catalog Number
F10244-2020P
Brand Name
OviTex Reinforced Bioscaffold With Permanent Polymer (OviTex)
Version/Model Number
F10244-2020P
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
K153632
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
58c5e93e-6734-43de-8b33-b406edc37504
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |
| U | Unclassified | 33 |