Hayden Medical
Durette IV External Laser Eye Shield Replacement Clear Plastic Attachments, NOT AUTOCLAVABLE....2 sets: incl. 4 nasals + 4 temporals
19manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | Hayden Medical Inc, United States |
|---|---|
| FDA product code | IWS |
| Device type | Shield, Eye, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-08-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP21-440 | In distribution | |
| OP21-550N | In distribution | |
| OP21-550T | In distribution | |
| OP21-555 | In distribution | |
| OP21-552 | In distribution |
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 |
| Haven | Burlington Medical, LLC | 4 |
| Bomber | 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.