Light Jacket
The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when…
The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil.
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Huifeng Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| HI-Life Technology (Hebei) Co., Ltd. | Bazhou | Hebei | Manufacturer | 11 |
| Shenzhen Youmay Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
Record
| Listed by | Pathy Medical, LLC |
|---|---|
| FDA product code | FTD |
| Device type | Lamp, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Premarket notification | Exempt |
| Record published | 2020-06-17 |
| Record revised | 2021-01-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -10 to 50 °C; Handling environment temperature 10 to 35 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 25 to 85 % RH; Handling environment humidity 30 to 75 % RH |
| Distribution end date | 2030-06-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PM-LJ100 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquet PowerLED II | Maquet Gmbh | 1,930 |
| S300 Series | Dentis Co., Ltd. | 41 |
| Standop Volista® | Maquet Gmbh | 32 |
| L400 Series | Dentis Co., Ltd. | 24 |
| M400 Series (Ceiling, Mobile) | Dentis Co., Ltd. | 24 |
| Lamp, Surgical | Maquet Gmbh | 18 |
| Maquet Ezea | Maquet Gmbh | 18 |
| Maisilide | Shandong Deman Medical Equipment Group Co., Ltd. | 15 |
| S250 Series(Ceiling, Mobile) | Dentis Co., Ltd. | 11 |
| Lucea LED® | Maquet Gmbh | 7 |
| StarTrol | Huot Instruments, LLC | 7 |
| Rolite Volista Standop | Maquet Gmbh | 5 |
Showing 12 of 52. All products under Lamp, 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.