A non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injection
| Company | Devices | Share |
|---|---|---|
| Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | 403 | 59% |
| Sonoscape Medical Corp. | 70 | 10% |
| Protek Medical Products, Inc. | 50 | 7% |
| Civco Medical Instruments Co., Inc. | 35 | 5% |
| Fujifilm Corporation | 33 | 5% |
| Best Nomos | 16 | 2% |
| Koelis | 14 | 2% |
| Bk Medical Aps | 11 | 2% |
| Gimmi Gmbh | 11 | 2% |
| Amplify Surgical, Inc. | 5 | 1% |
| Exact Imaging Inc | 4 | 1% |
| Spiggle & Theis Medizintechnik Gmbh | 3 | 0% |
Company = labeler of record on GUDID. 28 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 |
|---|---|---|
| OIJ | Biopsy Needle Guide Kit | 531 |
| ITX | Transducer, Ultrasonic, Diagnostic | 108 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 35 |
| IYO | System, imaging, pulsed echo, ultrasonic | 35 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 33 |
| IWJ | System, Applicator, Radionuclide, Manual | 16 |
Use these as the dimensions to specify in a tender line.
685 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Needle guide, reusable", from 28 companies. The largest labeler is Jingfang Precision Medical Device(Shenzhen) Co., Ltd. with 59% of records.
OIJ (Biopsy Needle Guide Kit), ITX (Transducer, Ultrasonic, Diagnostic), IYN (System, Imaging, Pulsed Doppler, Ultrasonic), 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.