Duns Number:078721472
Device Description: OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients
Catalog Number
-
Brand Name
OviTex® PRS
Version/Model Number
R20153-1620G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K183398
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
d0fb6a24-b284-4c9e-b905-6e5f2a6d38f8
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 14, 2020
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |