Scharf
A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract hair follicles [follicular unit extraction (FUE)] and may…
A hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Record
| Listed by | Scharf Tools Ihracat Ithalat Limited Sirketi, Türkiye |
|---|---|
| FDA product code | LRY |
| Device type | Punch, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-12-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 0.6 mm; width 0.7 to 0.75 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| serrated fue punch 0.9-3.5mm | In distribution | |
| Serrated Fue punch 0.75-5mm | Width 0.75 mm | In distribution |
| serrated fue punch 0.85-4mm | In distribution | |
| serrated fue punch 0.9-5mm | In distribution | |
| serrated fue punch 0.95-2.5mm | In distribution | |
| Fue Punch non serrated0.7 mm 2.5mm | Length 0.6 mm | In distribution |
| serrated fue punch 1mm-3.5mm | In distribution | |
| serrated fue punch 0.95-4mm | In distribution | |
| serrated fue punch 0.95-5mm | In distribution | |
| SerrATED FUE | Width 0.7 mm | In distribution |
| serrated fue punch 0.85-5mm | In distribution | |
| serrated fue punch 0.9-2.5mm | In distribution | |
| serrated fue punch 1mm-2.5mm | In distribution | |
| serrated fue punch 1mm-4mm | In distribution | |
| serrated fue punch 0.8-2.5mm | In distribution | |
| serrated fue punch 1mm5mm | In distribution | |
| Fue Punch serrtaed 0.6 mm 4mm | Length 0.6 mm | In distribution |
| serrated fue punch 0.8-3.5mm | In distribution | |
| Fue Punch serrated | Length 0.6 mm | In distribution |
| serrated fue punch 0.8-5mm | In distribution | |
| serrated fue punch 0.95-3.5mm | In distribution | |
| serrated fue punch 0.8-4mm | In distribution | |
| Serrated Fue punch | Width 0.75 mm | In distribution |
| serrated fue punch 0.9-4mm | In distribution | |
| serrated fue punch 0.85-3.5mm | In distribution | |
| Fue Punch non serrated0.7 mm 23.5mm | Length 0.6 mm | In distribution |
| serrated fue punch 0.85-2.5mm | In distribution | |
| serrated fue punch 0.75-3.5mm | In distribution | |
| serrated fue punch 0.75-2.5mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 693 |
| Ambler Surgical | Ambler Surgical, LLC | 317 |
| Orthomed | Ortho-MED, Inc. | 228 |
| Aesculap | Aesculap AG | 187 |
| Lazic | Peter Lazic Gmbh | 148 |
| Noir | Aesculap AG | 66 |
| MaxMoreSpine | Hoogland Spine Products GmbH | 44 |
| Kerrison | Elliquence LLC | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 33 |
| Punch, Surgical | Doppkon Gmbh & Co. KG | 29 |
| Henry Schein | Henry Schein, Inc. | 27 |
| ACE | Ace Surgical Supply Co., Inc. | 25 |
Showing 12 of 216. All products under Punch, 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.