Sandel
Sandel Safety Scalpel Handle-Long, CAB (NS)
29manufacturers in China registered for this device type
3catalogue numbers in this listing
7recalls on this 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 | Ansell Sandel Medical Solutions 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 | 2022-03-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 4, case |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2204 | 12 | In distribution | |
| 2200-LNS | 200 | In distribution | |
| 2204-NS | 50 | 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
7 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2013-11-12 | Class II | Under Investigation by firm | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. | 50 cases (4800 units); 96 cases (576 units) | 2016-04-06 |
| 2013-11-12 | Class II | Under Investigation by firm | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. | 96 cases (1920 units) | 2016-04-06 |
| 2013-11-12 | Class II | Under Investigation by firm | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. | 1203 – 96 cases (4128 units) ; 1553 -96 cases (3548 units) | 2016-04-06 |
| 2013-11-12 | Class II | Under Investigation by firm | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. | 13 cases (312 units); 24 cases (1176 units) | 2016-04-06 |
| 2013-11-12 | Class II | Under Investigation by firm | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. | 15 cases (1440 units); 96 cases (96 units); 96 cases (2880 u | 2016-04-06 |
| 2013-11-12 | Class II | Under Investigation by firm | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. | 96 cases (288 units) | 2016-04-06 |
| 2013-11-12 | Class II | Under Investigation by firm | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. | 48 cases (384 units) | 2016-04-06 |
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.