A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel
| Company | Devices | Share |
|---|---|---|
| Surgistar, Inc. | 306 | 16% |
| Beijing Bohai Kangyuan Medical Devices Co., Ltd. | 298 | 16% |
| Unique Technologies, Inc. | 223 | 12% |
| Surgical Specialties México, S. De R.L. De C.V. | 210 | 11% |
| Swann-Morton Limited | 166 | 9% |
| Med Saver, Inc. | 123 | 7% |
| Deroyal Industries, Inc. | 44 | 2% |
| Aesculap Ag | 39 | 2% |
| Surgical Design, Inc. | 36 | 2% |
| Aspen Surgical Products, Inc. | 33 | 2% |
| Feather Safety Razor Co., Ltd. | 29 | 2% |
| Southmedic Incorporated | 27 | 1% |
Company = labeler of record on GUDID. 71 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 |
|---|---|---|
| HNN | Knife, ophthalmic | 458 |
| EMF | Knife, Surgical | 320 |
| GDZ | Handle, Scalpel | 303 |
| GDX | Scalpel, One-Piece | 296 |
| GDX | SCALPEL, ONE-PIECE | 127 |
| HNF | SCISSORS, OPHTHALMIC | 95 |
Use these as the dimensions to specify in a tender line.
1,869 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Scalpel, single-use", from 71 companies. The largest labeler is Surgistar, Inc. with 16% of records.
HNN (Knife, ophthalmic), EMF (Knife, Surgical), GDZ (Handle, Scalpel), GDX (Scalpel, One-Piece)
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.