| Primary Device ID | 07333387052847 |
| NIH Device Record Key | 303e2047-bf93-4cee-931e-60c945d5e0b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navina Mini Extension Set |
| Version Model Number | 6930840 |
| Catalog Number | 6930840 |
| Company DUNS | 351118942 |
| Company Name | Wellspect AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 07333387054537 - LoFric® Origo™ | 2025-12-02 Single Use Urinary Catheter with salt solution. LoFric Origo Sleeve Coudé FX Male 40cm FR12, Sterile device. |
| 07333387054575 - LoFric® Origo™ | 2025-12-02 Single Use Urinary Catheter with salt solution. LoFric Origo Sleeve Coudé FX Male 40cm FR14, Sterile device. |
| 07333387054605 - LoFric® Origo™ | 2025-12-02 Single Use Urinary Catheter with salt solution. LoFric Origo Sleeve Coudé FX Male 40cm FR16, Sterile device. |
| 07333387054353 - LoFric® Origo™ | 2025-08-04 Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH12 / Coudé FX 16" 12FR, Sterile device. |
| 07333387054377 - LoFric® Origo™ | 2025-08-04 Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH14 / Coudé FX 16" 14FR, Sterile device. |
| 07333387054421 - LoFric® Origo™ | 2025-08-04 Single Use Urinary Catheter with salt solution. LoFric Origo Coudé FX Male 40cm CH16 / Coudé FX 16" 16FR, Sterile device. |
| 07333387052564 - Navina™ Catheter Set Cone | 2025-01-20 Navina Transanal Irrigation. Rectal Catheter set cone. 10 Rectal catheters cone. Single use. Non sterile Device.
Rx Only. |
| 07333387052595 - Navina™ Classic System Regular | 2025-01-20 Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 1 Accessory set, 1 Navina cas |