A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications [e.g., to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostati
| Company | Devices | Share |
|---|---|---|
| Omniguide, Inc. | 50 | 34% |
| Weinert Fiber Optics, Inc. | 47 | 32% |
| Maxiflex, Llc | 20 | 14% |
| Fortec Fibers, Inc. | 10 | 7% |
| Cook Incorporated | 8 | 6% |
| Acquire Med | 6 | 4% |
| Coloplast A/S | 4 | 3% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| GEX | Powered laser surgical instrument | 84 |
| GEX | Powered Laser Surgical Instrument | 70 |
Use these as the dimensions to specify in a tender line.
145 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urogenital surgical laser system beam guide, reusable", from 7 companies. The largest labeler is Omniguide, Inc. with 34% of records.
GEX (Powered laser surgical instrument), GEX (Powered Laser Surgical Instrument)
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.