A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides a
| Company | Devices | Share |
|---|---|---|
| Zhejiang Curaway Medical Technology Co., Ltd. | 264 | 19% |
| Civco Medical Instruments Co., Inc. | 209 | 15% |
| Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | 144 | 10% |
| Protek Medical Products, Inc. | 137 | 10% |
| Argon Medical Devices, Inc. | 101 | 7% |
| Medax Srl Unipersonale | 101 | 7% |
| Möller Medical Gmbh | 64 | 5% |
| Bard Peripheral Vascular, Inc. | 37 | 3% |
| Philips Ds North America Llc | 35 | 3% |
| Philips Medical Systems Nederland B.V. | 34 | 2% |
| Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi | 29 | 2% |
| Apriomed Ab | 18 | 1% |
Company = labeler of record on GUDID. 60 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 |
|---|---|---|
| KNW | Instrument, Biopsy | 533 |
| ITX | Transducer, ultrasonic, diagnostic | 246 |
| ITX | Transducer, Ultrasonic, Diagnostic | 185 |
| OIJ | Biopsy Needle Guide Kit | 158 |
| KNW | INSTRUMENT, BIOPSY | 76 |
| GDF | Guide, Needle, Surgical | 55 |
Use these as the dimensions to specify in a tender line.
1,398 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Needle guide, single-use", from 60 companies. The largest labeler is Zhejiang Curaway Medical Technology Co., Ltd. with 19% of records.
KNW (Instrument, Biopsy), ITX (Transducer, ultrasonic, diagnostic), ITX (Transducer, Ultrasonic, Diagnostic), OIJ (Biopsy Needle Guide Kit)
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.