A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperat
| Company | Devices | Share |
|---|---|---|
| Sheathing Technologies, Inc. | 161 | 53% |
| Microtek Medical Llc | 81 | 27% |
| Protek Medical Products, Inc. | 31 | 10% |
| Civco Medical Instruments Co., Inc. | 24 | 8% |
| Hr Pharmaceuticals Inc. | 2 | 1% |
| Exact Medical Manufacturing, Inc. | 1 | 0% |
| Clear Guide Medical, Inc. | 1 | 0% |
| Medline Industries, Inc. | 1 | 0% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| OIP | Radiology-Diagnostic Kit | 110 |
| ITX | Transducer, Ultrasonic, Diagnostic | 52 |
| PUI | Drape, Surgical, Exempt | 45 |
| KKX | Drape, surgical | 42 |
| KKX | Drape, Surgical | 32 |
| ITX | Transducer, ultrasonic, diagnostic | 31 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
302 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intraoperative ultrasound imaging transducer cover", from 8 companies. The largest labeler is Sheathing Technologies, Inc. with 53% of records.
OIP (Radiology-Diagnostic Kit), ITX (Transducer, Ultrasonic, Diagnostic), PUI (Drape, Surgical, Exempt), KKX (Drape, surgical)
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.