A personal protective device intended to shield the head of an individual (i.e., the operator or other attending person) from unnecessary primary and scattered radiation during diagnostic or therapeutic medical procedures. It can be shaped like a cap or hood a
| Company | Devices | Share |
|---|---|---|
| Burlington Medical, Llc | 154 | 92% |
| Texray Ab | 13 | 8% |
| Amsino International, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 3 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 |
|---|---|---|
| KPY | Shield, Protective, Personnel | 137 |
| IWO | Apron, Protective | 30 |
| LKB | Pad, Alcohol, Device Disinfectant | 1 |
Use these as the dimensions to specify in a tender line.
168 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiation shielding head wear", from 3 companies. The largest labeler is Burlington Medical, Llc with 92% of records.
KPY (Shield, Protective, Personnel), IWO (Apron, Protective), LKB (Pad, Alcohol, Device Disinfectant)
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.