Unfolder Emerald
PKG Assy Emeraldt CE Mark Hndpc, 690694
1manufacturer
3catalogue 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 | Johnson & Johnson Surgical Vision, Inc., United States |
|---|---|
| FDA product code | KYB |
| Device type | Lens, Guide, Intraocular |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4300 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K961242 |
| Record published | 2019-02-13 |
| Record revised | 2022-12-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 30 °C; Handling environment temperature 5 to 30 °C |
| Packaging | Box of 30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EMERALDT | In distribution | |
| EMERALDXL | In distribution | |
| EMERALDC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Duckworth & Kent | Duckworth AND Kent Limited | 5 |
| 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 |
| IOL Manipulator – Sinskey | Hurricane Medical | 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.