IOL Manipulator – Sinskey
Positioning of intraocular lens. Angled 15 mm from tip. Tip dimensions: diameter 0.20 mm, length 0.50 mm.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Hurricane Medical, United States |
|---|---|
| FDA product code | KYB |
| Device type | Lens, Guide, Intraocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4300 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Radiation Sterilization, Ethylene Oxide |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 24 to 27 mm; outer diameter 0.2 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6804 | Length 27 mm | 5 | In distribution |
| 6802 | Length 24 mm | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Duckworth & Kent | Duckworth AND Kent Limited | 5 |
| Unfolder Emerald | Johnson & Johnson Surgical Vision, Inc. | 3 |
| Monarch® II | Alcon Laboratories, Inc. | 2 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 2 |
| Unfolder Silver | Johnson & Johnson Surgical Vision, Inc. | 2 |
| Monarch® III | Alcon Laboratories, Inc. | 2 |
| Lens Exchange Sytem | Visioncare Ophthalmic Technologies Ltd. | 2 |
| Viscoject 1.8 Injector Set | Medicel AG | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
| Nucleus Chopper – P. Koch | Hurricane Medical | 1 |
| Surgical Glide | Hurricane Medical | 1 |
| Unfolder Platinum 1 Series | Johnson & Johnson Surgical Vision, Inc. | 1 |
Showing 12 of 18. All products under Lens, Guide, Intraocular
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.