UDI device identifier
Freedom - ProFlor Inguinal Hernia Kit FIHR 25mmEK
UDI device identifier 00013964672367 · INSIGHTRA MEDICAL, INC.
Key facts
| Primary DI | 00013964672367 |
|---|---|
| Brand name | Freedom - ProFlor Inguinal Hernia Kit |
| Version or model | FIHR 25mmEK |
| Catalog number | FIHR 25mmEK |
| Company | INSIGHTRA MEDICAL, INC. |
| DUNS number | 097664937 |
| Product code | FTL |
| GMDN term | Extra-gynaecological surgical mesh, composite-polymer |
| Premarket submission | K140967 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | Yes |
| Publish date | Jul 22, 2015 |
| Version date | Jun 10, 2022 |
| 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. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: