A rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typicall
| Company | Devices | Share |
|---|---|---|
| Medicon Eg. Chirurgiemechaniker-Genossenschaft | 165 | 36% |
| Karl Storz Gmbh & Co. Kg | 62 | 14% |
| Ambler Surgical Corp. | 61 | 13% |
| Sopro-Comeg Gmbh | 40 | 9% |
| Grace Manufacturing, Inc. | 31 | 7% |
| Novo Surgical, Inc. | 30 | 7% |
| Rz-Medizintechnik Gmbh | 18 | 4% |
| Steris Corporation | 17 | 4% |
| Surgipros, Llc | 13 | 3% |
| American Medicals | 12 | 3% |
| Hermann Medizintechnik Gmbh | 7 | 2% |
| Avalign Technologies, Inc. | 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 |
|---|---|---|
| FBX | SOUND, URETHRAL, METAL OR PLASTIC | 167 |
| EZN | DILATOR, CATHETER, URETERAL | 55 |
| FAX | BOUGIE, UROLOGICAL | 48 |
| FAX | Bougie, Urological | 48 |
| FAJ | Cystoscope and accessories, flexible/rigid | 34 |
| FBS | SOUND, METAL, INTERCONNECTED | 33 |
Use these as the dimensions to specify in a tender line.
458 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urethral bougie, reusable", from 13 companies. The largest labeler is Medicon Eg. Chirurgiemechaniker-Genossenschaft with 36% of records.
FBX (SOUND, URETHRAL, METAL OR PLASTIC), EZN (DILATOR, CATHETER, URETERAL), FAX (BOUGIE, UROLOGICAL), FAX (Bougie, Urological)
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.