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, sold separately, is used to deploy the implant into the prepared hernia defect site.
Catalog Number
FIHR 25mmE
Brand Name
Freedom - ProFlor Inguinal Hernia Implant
Version/Model Number
FIHR 25mmE
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"
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,K140967,K140967
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
2af716e4-c406-436f-b490-555e64d0c35c
Public Version Date
June 10, 2022
Public Version Number
9
DI Record Publish Date
July 22, 2015
Package DI Number
00013964672343
Quantity per Package
6
Contains DI Package
00850012832041
Package Discontinue Date
July 14, 2020
Package Status
Not in Commercial Distribution
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 |