Pilling
21 catalogue numbers from IPN016752, listed by Teleflex Medical LLC, United States, under Handle, Scalpel. 29 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (9), Zhejiang (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Xiantao Sanda Industrial Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 10 |
| Ningbo Medsun Medical Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 29. All 29 manufacturers in China registered for Handle, Scalpel
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GDZ |
| Device type | Handle, Scalpel |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2026-02-11 (version 3) |
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, serial number |
| Sizes | Length 12 to 21.2 cm; length 90 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN016752 | In distribution | |
| IPN016750 | In distribution | |
| IPN016748 | In distribution | |
| IPN016746 | In distribution | |
| IPN003901 | In distribution | |
| IPN007935 | Length 90 mm | In distribution |
| IPN005595 | Length 12.5 cm | In distribution |
| IPN016741 | In distribution | |
| IPN016749 | In distribution | |
| IPN005600 | Length 16.3 cm | In distribution |
| IPN016745 | In distribution | |
| IPN005596 | Length 21.2 cm | In distribution |
| IPN005601 | Length 12 cm | In distribution |
| IPN928876 | In distribution | |
| IPN016743 | In distribution | |
| IPN005599 | Length 21.2 cm | In distribution |
| IPN005597 | Length 20.5 cm | In distribution |
| IPN016742 | In distribution | |
| IPN016753 | In distribution | |
| IPN003902 | In distribution | |
| IPN005598 | Length 13.6 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| comknife® | Beijing Bohai Kangyuan Medical Devices Co., Ltd. | 298 |
| Surgical Direct | Surgical Direct, Inc. | 68 |
| Millennium | Avalign Technologies, Inc. | 46 |
| Aesculap | Aesculap AG | 41 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 37 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 31 |
| V. Mueller | Steris Corporation | 31 |
| gSource | Gsource, LLC. | 29 |
| Handle | KLS-Martin L.P. | 28 |
| Sklar® | Sklar Corporation | 28 |
Showing 12 of 226. All products under Handle, Scalpel
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2014-09-26 | Class II | Process control | The knife handles slot depth is out of specification, so blades may not fit on the handles properly. | 6197 units |
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.