Durette® II, SS External Ocular Laser Shields, Small (Non Glare)
Durette® II External laser shields are designed to protect patient's eyes during laser treatment. They are installed on the face over the eyelids. It is provided with a fastening system…
Durette® II External laser shields are designed to protect patient’s eyes during laser treatment. They are installed on the face over the eyelids. It is provided with a fastening system that fits as many people as possible. The regular size is used in most treatments on the face, while the small size is used when the surgeon wants to go closer to the eyes. The entire surface of the device is non-glare treated to diffuse the laser. The medical staff uses the instrument during surgery. It must be cleaned and sterilized before use.
Who Else Makes It
Concentrated in Guangdong (9), Hebei (4), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Guangdong Xinuo Personal Care Products Co., Ltd. | Yunfu | Guangdong | Manufacturer | 33 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
| Shenzhen JIE Bishi Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Guangdong Dexin Sports Industry Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 13 |
| Shenzhen Margotan Tech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
Showing 12 of 19. All 19 manufacturers in China registered for Shield, Eye, Radiological
Record
| Listed by | Oculo Plastik, Inc., Canada |
|---|---|
| FDA product code | IWS |
| Device type | Shield, Eye, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-11-07 |
| Record revised | 2022-03-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Distribution end date | 2022-03-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21-334 | In distribution | |
| 21-334S | Withdrawn | |
| 21-334R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rayshield | Aadco Medical, Inc. | 101 |
| Nike | Burlington Medical, LLC | 36 |
| Super Sunnies | Lucas Specialty Products | 19 |
| Kate Spade | Burlington Medical, LLC | 12 |
| Pentax | Burlington Medical, LLC | 12 |
| Under Armour | Burlington Medical, LLC | 12 |
| Oakley | Burlington Medical, LLC | 8 |
| Liberty | Burlington Medical, LLC | 8 |
| Ray-Ban | Burlington Medical, LLC | 8 |
| ArmourX | Burlington Medical, LLC | 8 |
| Hayden Medical | Hayden Medical Inc | 5 |
| Haven | Burlington Medical, LLC | 4 |
Showing 12 of 55. All products under Shield, Eye, Radiological
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.