A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip)
| Company | Devices | Share |
|---|---|---|
| Avalign Technologies, Inc. | 25 | 29% |
| Elmed Incorporated | 15 | 18% |
| Integra Lifesciences Production Corporation | 11 | 13% |
| Medtronic Ps Medical, Inc. | 8 | 9% |
| Ambler Surgical Corp. | 8 | 9% |
| Natus Medical Incorporated | 6 | 7% |
| Teleflex Incorporated | 4 | 5% |
| Aesculap Ag | 3 | 4% |
| Novo Surgical, Inc. | 3 | 4% |
| Sophysa | 2 | 2% |
Company = labeler of record on GUDID. 10 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 |
|---|---|---|
| EYR | TOURNIQUET, GASTRO-UROLOGY | 24 |
| PIY | Stainless Steel Instrument, Shunt System Implantation | 23 |
| JXG | Shunt, central nervous system and components | 15 |
| PIY | Stainless steel instrument, shunt system implantation | 10 |
| GYK | Instrument, shunt system implantation | 5 |
| GYK | Instrument, Shunt System Implantation | 3 |
Use these as the dimensions to specify in a tender line.
85 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Subcutaneous tunneller, reusable", from 10 companies. The largest labeler is Avalign Technologies, Inc. with 29% of records.
EYR (TOURNIQUET, GASTRO-UROLOGY), PIY (Stainless Steel Instrument, Shunt System Implantation), JXG (Shunt, central nervous system and components), PIY (Stainless steel instrument, shunt system implantation)
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.