A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or surgical procedure (e.g., femoral artery catheterization). It is a
| Company | Devices | Share |
|---|---|---|
| Nuvasive, Inc. | 39 | 49% |
| Icotec Ag | 8 | 10% |
| Karl Storz Gmbh & Co. Kg | 7 | 9% |
| Kalitec Direct Llc | 6 | 8% |
| National Advanced Endoscopy Devices, Inc. | 5 | 6% |
| Genesys Orthopedics Systems Llc | 4 | 5% |
| Summit Spine Llc | 3 | 4% |
| Seaspine Orthopedics Corporation | 3 | 4% |
| American Medical Endoscopy, Inc. | 2 | 2% |
| Takayama Instruments Inc. | 1 | 1% |
| Cook Incorporated | 1 | 1% |
| Alphatec Spine, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 12 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 |
|---|---|---|
| ETN | STIMULATOR, NERVE | 30 |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 9 |
| OLO | Orthopedic Stereotaxic Instrument | 8 |
| NKB | Thoracolumbosacral Pedicle Screw System | 8 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 6 |
| GEI | Electrosurgical, cutting & coagulation & accessories | 5 |
Use these as the dimensions to specify in a tender line.
80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fascial tissue dilator, reusable", from 12 companies. The largest labeler is Nuvasive, Inc. with 49% of records.
ETN (STIMULATOR, NERVE), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), OLO (Orthopedic Stereotaxic Instrument), NKB (Thoracolumbosacral Pedicle Screw System)
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.