Nucleus Chopper – P. Koch
Used to break-up nucleus within capsular bag during phacoemulsification. Angled 6 mm from tip. Tip dimensions: diameter 0.30 mm, length 1.50 mm.
1manufacturer
1catalogue number
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 14 mm; outer diameter 0.3 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6810 | Length 14 mm | 5 | In distribution |
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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.