A system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust f
| Company | Devices | Share |
|---|---|---|
| Stryker Corporation | 35 | 44% |
| Zimmer Orthopaedic Surgical Products, Inc. | 22 | 28% |
| Syntech, Int'L Inc. | 10 | 13% |
| Thi Total Healthcare Innovation Gmbh | 6 | 8% |
| Dupaco, Inc. | 5 | 6% |
| Zimmer, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| FXZ | HELMET, SURGICAL | 26 |
| FYA | GOWN, SURGICAL | 16 |
| LYU | ACCESSORY, SURGICAL APPAREL | 9 |
| LYU | Accessory, Surgical Apparel | 8 |
| FYA | Gown, Surgical | 7 |
| FXZ | Helmet, Surgical | 6 |
Use these as the dimensions to specify in a tender line.
79 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical helmet system", from 6 companies. The largest labeler is Stryker Corporation with 44% of records.
FXZ (HELMET, SURGICAL), FYA (GOWN, SURGICAL), LYU (ACCESSORY, SURGICAL APPAREL), LYU (Accessory, Surgical Apparel)
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.