Super View® Disposable Lens Set, Essential
SUPER VIEW® Sterile Essential Lens Pack for use with the SUPER VIEW® System and the BIOM®
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
Record
| Listed by | Oculus Surgical Inc, United States |
|---|---|
| FDA product code | HJL |
| Device type | Lens, Condensing, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1380 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2022-06-17 (version 6) |
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, manufacturing date |
| Packaging | Case of 20 |
| Sizes | Outer diameter 18 to 42 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40403 | Outer Diameter 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MaxLight® Standard 90D Slit Lamp Indirect Lens w/Large Ring | Ocular Instruments, Inc. | 6 |
| MaxField® Standard 90D Slit Lamp Indirect Lens w/Large Ring (Red) | Ocular Instruments, Inc. | 6 |
| MaxLight® Triple Two Panfundus Binocular Indirect Lens (Purple) | Ocular Instruments, Inc. | 6 |
| Righton | Right MFG. Co., Ltd. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 3 |
| Ophthalmoscopy Lens A.R. | Heine Optotechnik Gmbh & Co. KG. | 3 |
| MaxLight® Ultra Mag 60D Slit Lamp Indirect Lens (Green) | Ocular Instruments, Inc. | 2 |
| DirectView 4 Mirror NF w/ Handle | ION Vision, Inc. | 2 |
| SuperField® NC, Custom Color | Volk Optical Inc. | 1 |
| Osher Maxfield® 78D Slit Lamp Indirect Lens (Green) | Ocular Instruments, Inc. | 1 |
| MaxField® High Mag 78 Slit Lamp Indirect Lens (Purple) | Ocular Instruments, Inc. | 1 |
| MaxField® 60D Slit Lamp Indirect Lens (Purple) | Ocular Instruments, Inc. | 1 |
Showing 12 of 354. All products under Lens, Condensing, Diagnostic
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.