A non-sterile 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) us
| Company | Devices | Share |
|---|---|---|
| Protek Medical Products, Inc. | 33 | 57% |
| Sheathing Technologies, Inc. | 16 | 28% |
| Microtek Medical Llc | 6 | 10% |
| Mckesson Medical-Surgical Inc. | 2 | 3% |
| Philips Medical Systems Hsg | 1 | 2% |
Company = labeler of record on GUDID. 5 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 |
|---|---|---|
| KKX | Drape, Surgical | 23 |
| ITX | Transducer, Ultrasonic, Diagnostic | 16 |
| KKX | Drape, surgical | 5 |
| IYO | System, imaging, pulsed echo, ultrasonic | 1 |
| JOP | TRANSDUCER, ULTRASONIC | 1 |
Use these as the dimensions to specify in a tender line.
58 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, non-sterile", from 5 companies. The largest labeler is Protek Medical Products, Inc. with 57% of records.
KKX (Drape, Surgical), ITX (Transducer, Ultrasonic, Diagnostic), KKX (Drape, surgical), IYO (System, imaging, pulsed echo, ultrasonic)
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.