Fresnel Prism AND Lens
Foil BAR, Bangerter
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Mingren Shikang Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Fresnel Prism & Lens Co., United States |
|---|---|
| FDA product code | NXR |
| Device type | Fixation, Vision Training, Binocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1290 |
| Establishment | Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-05 |
| Record revised | 2023-02-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Storage | Special storage condition: STORE AWAY FROM HEAT AND KEEP DRY |
| Distribution end date | 2023-02-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6300-B | In distribution | |
| 6300-1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Otus® Fixation, Vision Training, Binocular | Edenlux Corp. | 1 |
| Brock String | Gulden Ophthalmics | 1 |
| NeuroEyeCoach | Novavision, Inc. | 1 |
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.