Scharf
A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece…
A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Scharf Tools Ihracat Ithalat Limited Sirketi, Türkiye |
|---|---|
| FDA product code | EMF |
| Device type | Knife, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-01-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 1.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| sapphire blades 1.1 | Height 1.5 mm | In distribution |
| sapphire 0.8 mm | In distribution | |
| sapphire blades 1.1 | Height 1.5 mm | In distribution |
| sapphire blades 1.5 | Height 1.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgistar | Surgistar, Inc. | 285 |
| Surtex | Surtex Instruments Ltd | 189 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 80 |
| Zoll-Dental | Zoll-Dental | 72 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 59 |
| Lazic | Peter Lazic Gmbh | 47 |
| Millennium | Avalign Technologies, Inc. | 40 |
| Aesculap | Aesculap AG | 38 |
| Sklar | Sklar Corporation | 35 |
| Stylus | Surgical Specialties México, S. de R.L. de C.V. | 32 |
| V. Mueller | Steris Corporation | 31 |
| Elmed | Elmed, Inc. | 30 |
Showing 12 of 122. All products under Knife, Surgical
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.