A non-sterile device designed specifically to cover the handle of a piece of medical equipment (e.g., examination/treatment light) to provide a hygienic barrier between the handle and the hand of a healthcare professional. It is typically a polymer device desi
| Company | Devices | Share |
|---|---|---|
| Cardinal Health, Inc. | 64 | 91% |
| Ultradent Products, Inc. | 4 | 6% |
| Led Dental Inc | 2 | 3% |
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 |
|---|---|---|
| FSY | Light, surgical, ceiling mounted | 57 |
| FTA | Light, surgical, accessories | 5 |
| PEM | Dental barriers and sleeves | 3 |
| NXV | Diagnostic Light, Soft Tissue Detector | 2 |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 2 |
| NPK | Barrier, synthetic, intraoral | 1 |
Use these as the dimensions to specify in a tender line.
70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medical equipment handle cover, single-use, non-sterile", from 3 companies. The largest labeler is Cardinal Health, Inc. with 91% of records.
FSY (Light, surgical, ceiling mounted), FTA (Light, surgical, accessories), PEM (Dental barriers and sleeves), NXV (Diagnostic Light, Soft Tissue Detector)
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.