A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may
| Company | Devices | Share |
|---|---|---|
| C. R. Bard, Inc. | 173 | 47% |
| Urocare Products, Inc. | 55 | 15% |
| Coloplast A/S | 45 | 12% |
| Hollister Incorporated | 38 | 10% |
| Argentum Medical, Llc | 16 | 4% |
| The Lighthouse For The Blind | 15 | 4% |
| Hr Pharmaceuticals Inc. | 10 | 3% |
| Shenzhen Weirui Technology Co., Ltd | 8 | 2% |
| Hoomsoins Inc | 2 | 1% |
| Flex Source International, Inc. | 2 | 1% |
| Wellspect Ab | 1 | 0% |
| Hk Damisen Technology Co., Limited | 1 | 0% |
Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| NNX | DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE | 273 |
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile | 57 |
| NOA | Device, Paste-On For Incontinence, Non-Sterile | 16 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 15 |
| NZU | Collector, Urine, Powered, Non Indwelling Catheter | 12 |
| KGX | Tape And Bandage, Adhesive | 6 |
Use these as the dimensions to specify in a tender line.
367 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urinary incontinence penis sheath/port, single-use", from 13 companies. The largest labeler is C. R. Bard, Inc. with 47% of records.
NNX (DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE), NNX (Device, Incontinence, Urosheath Type, Non-Sterile), NOA (Device, Paste-On For Incontinence, Non-Sterile), KOA (Surgical Instruments, G-U, Manual (And Accessories))
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.