A sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical fie
| Company | Devices | Share |
|---|---|---|
| Protek Medical Products, Inc. | 18 | 34% |
| Carestream Health, Inc. | 12 | 23% |
| Sterimed Llc | 8 | 15% |
| Dexis Llc | 4 | 8% |
| Henry Schein, Inc. | 4 | 8% |
| Carestream Dental Llc | 3 | 6% |
| Gendex Corp. | 2 | 4% |
| Microtek Medical Llc | 1 | 2% |
| Edwards Lifesciences Llc | 1 | 2% |
Company = labeler of record on GUDID. 9 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 |
|---|---|---|
| KQM | CAMERA, SURGICAL AND ACCESSORIES | 21 |
| KKX | Drape, Surgical | 17 |
| ITX | Transducer, Ultrasonic, Diagnostic | 8 |
| IZI | System, X-Ray, Angiographic | 8 |
| PEM | Dental barriers and sleeves | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
Use these as the dimensions to specify in a tender line.
53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cable/lead/sensor/probe cover, sterile", from 9 companies. The largest labeler is Protek Medical Products, Inc. with 34% of records.
KQM (CAMERA, SURGICAL AND ACCESSORIES), KKX (Drape, Surgical), ITX (Transducer, Ultrasonic, Diagnostic), IZI (System, X-Ray, Angiographic)
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.