Duns Number:594540572
Device Description: OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile biosc OviTex™ 2S Reinforced Tissue Matrix with Resorbable Polymer (OviTex 2S) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and polyglycolic acid (PGA). OviTex 2S will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. OviTex 2S 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
F10258-1020G
Brand Name
OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex)
Version/Model Number
F10258-1020G
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
K153633
Product Code
FTM
Product Code Name
Mesh, Surgical
Public Device Record Key
7ee4f815-34ab-4877-9db7-6902762ef32a
Public Version Date
June 10, 2022
Public Version Number
7
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 |