A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomi
| Company | Devices | Share |
|---|---|---|
| Ningbo Xinwell Medical Technology Co., Ltd. | 150 | 72% |
| Micro-Tech (Nanjing) Co., Ltd. | 33 | 16% |
| Alton (Shanghai) Medical Instruments Co., Ltd. | 12 | 6% |
| Wilson Instruments (Shanghai) Co., Ltd. | 6 | 3% |
| Carbon Medical Technologies, Inc. | 3 | 1% |
| Palette Life Sciences, Inc. | 2 | 1% |
| Stradis Medical, Llc | 1 | 0% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 217 |
| OVB | Hydrogel Spacer | 1 |
| LNM | Agent, Bulking, Injectable For Gastro-Urology Use | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
Use these as the dimensions to specify in a tender line.
207 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Submucosal injection needle", from 7 companies. The largest labeler is Ningbo Xinwell Medical Technology Co., Ltd. with 72% of records.
FBK (Endoscopic Injection Needle, Gastroenterology-Urology), OVB (Hydrogel Spacer), LNM (Agent, Bulking, Injectable For Gastro-Urology Use), GAA (Needle, Aspiration And Injection, Disposable)
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.