Skytron Flexible Light Handle Cover
Catalogue number B1-530-16, listed by Aspen Surgical Products, Inc., United States, under Light, Surgical, Accessories. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (6), Guangdong (4). 8 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 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Rongxing Plastic Jurong Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 8 |
| Shanghai Everpure Plastics Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
Showing 12 of 21. All 21 manufacturers in China registered for Light, Surgical, Accessories
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | FTA |
| Device type | Light, Surgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K020304 |
| Record published | 2021-02-25 |
| Record revised | 2022-11-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B1-530-16 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aspen® Flexible Light Handle Adapter | Aspen Surgical Products, Inc. | 290 |
| Litex | Litex Manufacturing, Inc. | 226 |
| DeRoyal | Deroyal Industries, Inc. | 215 |
| Aspen® Rigid Light Handle Adapter | Aspen Surgical Products, Inc. | 212 |
| Light, Surgical, Accessories | Maquet Gmbh | 72 |
| Medical Action Industries | Medical Action Industries, Inc. | 42 |
| Olympus | Gyrus Acmi, Inc. | 37 |
| Aspen® Flexible Light Handle Cover | Aspen Surgical Products, Inc. | 14 |
| Helion | Videomed SRL | 14 |
| Cardinal Health | Cardinal Health 200, LLC | 13 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 8 |
| Aspen® Rigid Light Handle Cover | Aspen Surgical Products, Inc. | 6 |
Showing 12 of 74. All products under Light, Surgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020304 | 2002-02-14 |
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.