Duns Number:459310140
Device Description: Round patch 10 cm is a round rigid mesh knitted with Polypropylene monofilament, indicate Round patch 10 cm is a round rigid mesh knitted with Polypropylene monofilament, indicated for open pre-peritonealumbilical hernia repairs; no sutures are needed to secure the mesh
Catalog Number
-
Brand Name
ROUND PATCH
Version/Model Number
HT1C10
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
ca7fa8ab-87e2-4915-b8f0-81cc3c1aa0be
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 |