| Primary Device ID | 07333387055329 |
| NIH Device Record Key | 7e25f950-983f-4fad-8599-ffdb40b26866 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surity Female External Catheter |
| Version Model Number | 38011 |
| Catalog Number | 38011 |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com | |
| Phone | +1(877)456-3742 |
| USinfo@wellspect.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07333387055312 [Package] Contains: 07333387056630 Package: [3 Units] In Commercial Distribution |
| GS1 | 07333387055329 [Package] Contains: 07333387056630 Package: [30 Units] In Commercial Distribution |
| GS1 | 07333387056630 [Primary] |
| GS1 | 07333387056821 [Package] Contains: 07333387055312 Package: [16 Units] In Commercial Distribution |
| GS1 | 07333387056838 [Package] Package: [3 Units] In Commercial Distribution |
| NZU | Collector, urine, powered, non indwelling catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-29 |
| Device Publish Date | 2025-12-19 |
| 07333387055329 - Surity Female External Catheter | 2025-12-29Non-invasive, single-use device for management of urinary incontinence in adults with female anatomy |
| 07333387055329 - Surity Female External Catheter | 2025-12-29 Non-invasive, single-use device for management of urinary incontinence in adults with female anatomy |
| 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. |