A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a
| Company | Devices | Share |
|---|---|---|
| Advance Medical Designs, Inc. | 166 | 58% |
| Aspen Surgical Products, Inc. | 18 | 6% |
| Xodus Medical, Inc. | 14 | 5% |
| Cardinal Health 200, Llc | 12 | 4% |
| Pharma Sept Medical Products (1995) Ltd. | 11 | 4% |
| Medical Action Industries Inc. | 8 | 3% |
| Microtek Medical Llc | 6 | 2% |
| Steris Corporation | 6 | 2% |
| Gri Medical & Electronic Technology Co., Ltd. | 5 | 2% |
| Owens & Minor Distribution, Inc. | 5 | 2% |
| Cardinal Health, Inc. | 5 | 2% |
| Deroyal Industries, Inc. | 4 | 1% |
Company = labeler of record on GUDID. 25 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 |
|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | 117 |
| FTA | Light, surgical, accessories | 114 |
| JAA | System, x-ray, fluoroscopic, image-intensified | 45 |
| FSY | Light, surgical, ceiling mounted | 19 |
| FTA | Light, Surgical, Accessories | 18 |
| KQM | Camera, Surgical And Accessories | 12 |
Use these as the dimensions to specify in a tender line.
286 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", from 25 companies. The largest labeler is Advance Medical Designs, Inc. with 58% of records.
ITX (Transducer, ultrasonic, diagnostic), FTA (Light, surgical, accessories), JAA (System, x-ray, fluoroscopic, image-intensified), FSY (Light, surgical, ceiling mounted)
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.