Duns Number:459310140
Device Description: Oval patch cm 14x18 is an oval rigid mesh knitted with Polypropylene monofilament, it is i Oval patch cm 14x18 is an oval rigid mesh knitted with Polypropylene monofilament, it is indicated for use in open pre-peritoneal ventral hernia repairs, no suture are needed to secure the mesh
Catalog Number
-
Brand Name
OVAL PATCH
Version/Model Number
OP1418
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
K973955,K973955
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
b5ac943a-4141-42da-9cbb-f3d86d479b44
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
August 02, 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. | 14 |