Identity
- Trade Name
- Freedom - ProFlor Inguinal Hernia Kit FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- FIHR 25mmK FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- FIHR 25mmK FDA UDI
- Primary DI / UDI-DI
- 00837654352878 FDA UDI
- 510(k) Number
- K113552 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 25 Millimeter FDA UDI
Freedom - ProFlor Inguinal Hernia Kit by Insightra Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Insightra Medical, Inc.
Sources (1)
- FDA UDI 53a5d8a6-19f2-4b2a-8d39-a6b4b1132291 38 fields · synced Jun 8, 2026