Duns Number:459310140
Device Description: Hermesh 7 cm 8x15 is a rectangular ultra-light macroporous mesh knitted with Polypropylene Hermesh 7 cm 8x15 is a rectangular ultra-light macroporous mesh knitted with Polypropylene monofilament, indicated for both open and laparoscopic hernia repair
Catalog Number
-
Brand Name
HERMESH 7
Version/Model Number
H70815
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 13, 2021
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
K070625,K070625
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
948bbeba-7d00-44e1-be87-2105c73e32e9
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
August 12, 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 |