A surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device.
| Company | Devices | Share |
|---|---|---|
| Microspecialities, Inc. | 45 | 48% |
| Med Logics Inc | 43 | 46% |
| Surgistar, Inc. | 5 | 5% |
| Sis Ag, Surgical Instrument Systems | 1 | 1% |
Company = labeler of record on GUDID. 4 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 |
|---|---|---|
| HNO | Keratome, Ac-Powered | 88 |
| GDX | Scalpel, One-Piece | 5 |
| HNY | Cystotome | 1 |
Use these as the dimensions to specify in a tender line.
94 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Keratome blade, single-use", from 4 companies. The largest labeler is Microspecialities, Inc. with 48% of records.
HNO (Keratome, Ac-Powered), GDX (Scalpel, One-Piece), HNY (Cystotome)
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.