A hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the i
| Company | Devices | Share |
|---|---|---|
| Avalign Technologies, Inc. | 12 | 13% |
| Integra Lifesciences Production Corporation | 10 | 11% |
| Aspen Surgical Products, Inc. | 8 | 9% |
| Novo Surgical, Inc. | 5 | 5% |
| Teleflex Incorporated | 4 | 4% |
| Steris Corporation | 4 | 4% |
| Sklar Corporation | 4 | 4% |
| Medicon Eg. Chirurgiemechaniker-Genossenschaft | 3 | 3% |
| Aesculap Ag | 3 | 3% |
| Boss Instruments, Ltd., Inc. | 3 | 3% |
| Hnm Stainless, Llc. | 3 | 3% |
| Gsource Llc | 3 | 3% |
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 |
|---|---|---|
| KCG | DILATOR, TRACHEAL | 36 |
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | 21 |
| KCG | Dilator, Tracheal | 17 |
| MDM | Instrument, Manual, Surgical, General Use | 6 |
| KCF | DILATOR, ESOPHAGEAL, ENT | 4 |
| EPY | SPECULUM, ENT | 3 |
Use these as the dimensions to specify in a tender line.
91 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tracheal surgery dilator, reusable", from 28 companies. The largest labeler is Avalign Technologies, Inc. with 13% of records.
KCG (DILATOR, TRACHEAL), LRC (INSTRUMENT, ENT MANUAL SURGICAL), KCG (Dilator, Tracheal), MDM (Instrument, Manual, Surgical, General Use)
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.