Duns Number:097664937
Device Description: The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropyle The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device is used to deploy the implant into the prepared hernia defect site.
Catalog Number
FIHR 25mmEK
Brand Name
Freedom - ProFlor Inguinal Hernia Kit
Version/Model Number
FIHR 25mmEK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 05, 2019
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"
Yes
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
K140967
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
35478468-9d68-4b8c-a383-bcb0b1a889c0
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
July 22, 2015
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. | 36 |