DeRoyal
SM62 Fine Surgical Blade Stainless Steel
29manufacturers in China registered for this device type
34catalogue numbers in this listing
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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | GDZ |
| Device type | Handle, Scalpel |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2020-02-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25, case of 50, case of 300, case of 100, case of 2000, case of 500 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM45SCNS | In distribution | |
| D4511A | In distribution | |
| D4506 | In distribution | |
| D4510 | In distribution | |
| D45S10 | In distribution | |
| D4524NS | In distribution | |
| 30-920NS | In distribution | |
| D45E11 | In distribution | |
| D4525A | In distribution | |
| D4510A | In distribution | |
| D4524 | In distribution | |
| D4515C | In distribution | |
| D45S7 | In distribution | |
| D0909 | In distribution | |
| D4516 | In distribution | |
| D4520NS | In distribution | |
| D4521 | In distribution | |
| D4SM-B2 | In distribution | |
| D4523 | In distribution | |
| D4523NS | In distribution | |
| D4515 | In distribution | |
| D6903 | In distribution | |
| D4522 | In distribution | |
| D5902 | In distribution | |
| D45S8 | In distribution | |
| D5909 | In distribution | |
| D4521NS | In distribution | |
| D45S9 | In distribution | |
| D4520 | In distribution | |
| D4525ANS | In distribution | |
| D4511 | In distribution | |
| D45S5 | In distribution | |
| 30-920 | In distribution | |
| D4522NS | 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 |
| 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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 27 |
Showing 12 of 226. All products under Handle, Scalpel
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.