A sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natura
| Company | Devices | Share |
|---|---|---|
| Sheathing Technologies, Inc. | 242 | 64% |
| Protek Medical Products, Inc. | 68 | 18% |
| Civco Medical Instruments Co., Inc. | 48 | 13% |
| Microtek Medical Llc | 15 | 4% |
| Vitrolife Sweden Ab | 3 | 1% |
| Aspen Surgical Products, Inc. | 1 | 0% |
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 |
|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 233 |
| KKX | Drape, Surgical | 67 |
| OIP | Radiology-Diagnostic Kit | 61 |
| ITX | Transducer, ultrasonic, diagnostic | 52 |
| PUI | Drape, Surgical, Exempt | 6 |
| KKX | Drape, surgical | 5 |
Use these as the dimensions to specify in a tender line.
377 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Body-orifice ultrasound imaging transducer cover, basic", from 6 companies. The largest labeler is Sheathing Technologies, Inc. with 64% of records.
ITX (Transducer, Ultrasonic, Diagnostic), KKX (Drape, Surgical), OIP (Radiology-Diagnostic Kit), ITX (Transducer, ultrasonic, diagnostic)
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.