A personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures.
| Company | Devices | Share |
|---|---|---|
| Burlington Medical, Llc | 132 | 45% |
| Aadco Medical, Inc. | 100 | 34% |
| Plasdent Corporation | 18 | 6% |
| Ultradent Products, Inc. | 16 | 5% |
| Barrier Technologies, Llc | 11 | 4% |
| Cao Group, Inc. | 7 | 2% |
| Den-Mat Holdings, Llc | 4 | 1% |
| Henry Schein, Inc. | 2 | 1% |
| Shandong Haidike Medical Products Co., Ltd. | 1 | 0% |
| Premium Plus (Dongguan) Limited | 1 | 0% |
| Jiangyin Chang-Hung Industrial Manufacturing Factory Llc | 1 | 0% |
| Phu Tuong Garment Company Limited | 1 | 0% |
Company = labeler of record on GUDID. 14 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 |
|---|---|---|
| IWS | Shield, Eye, Radiological | 243 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea | 42 |
| GEX | Powered Laser Surgical Instrument | 7 |
| HOY | Shield, eye, ophthalmic (including sunlamp protective eyewea | 3 |
| QNF | Laser Activator For Polymerization | 2 |
| IWS | Shield, eye, radiological | 2 |
Use these as the dimensions to specify in a tender line.
296 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiation shielding goggles/spectacles", from 14 companies. The largest labeler is Burlington Medical, Llc with 45% of records.
IWS (Shield, Eye, Radiological), HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea), GEX (Powered Laser Surgical Instrument), HOY (Shield, eye, ophthalmic (including sunlamp protective eyewea)
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.