Duns Number:459310140
Device Description: Hertra 5 is a standard macroporous pre-shaped mesh with hole knitted with Polypropylene mo Hertra 5 is a standard macroporous pre-shaped mesh with hole knitted with Polypropylene monofilament, indicated for the treatment of inguinal hernias, with open technique.
Catalog Number
-
Brand Name
HERTRA 5
Version/Model Number
HTR05
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
c0c3197d-d20f-4744-ae80-e2a5e4806717
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 13, 2021
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 |