Oertli®
Phaco pack Faros/CataRhex 3/Swisstech: tubing set, easyTip 2.2 mm 40°, irrigation sleeve, phaco key, emergency key, test chamber, I/A bimanual, infusion set, drainage bag, cover for remote…
Phaco pack Faros/CataRhex 3/Swisstech: tubing set, easyTip 2.2 mm 40°, irrigation sleeve, phaco key, emergency key, test chamber, I/A bimanual, infusion set, drainage bag, cover for remote control, sterile/single use, box of 10
4manufacturers in China registered for this device type
66catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Record
| Listed by | Oertli Instrumente AG, Switzerland |
|---|---|
| FDA product code | HQC |
| Device type | Unit, Phacofragmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4670 |
| Establishment | Manufacturer |
| 510(k) | K233398 |
| Record published | 2016-09-20 |
| Record revised | 2026-06-26 (version 11) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 10, pack of 6, carton of 10 |
| Sizes | Needle gauge 19 to 25 G |
| Distribution end date | 2026-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VV806835 | In distribution | |
| VE830011 | In distribution | |
| VE654101 | In distribution | |
| VV621011DE2 | In distribution | |
| VV621011DEB2 | In distribution | |
| VV806833A | In distribution | |
| VV621011AE | In distribution | |
| VV621010 | In distribution | |
| VV105110 | Needle Gauge 25 G | In distribution |
| VE820001 | In distribution | |
| VV800831 | In distribution | |
| VE201726 | In distribution | |
| VE800100 | In distribution | |
| VV621010A | In distribution | |
| VV650010 | In distribution | |
| VE201730 | In distribution | |
| VE654100 | In distribution | |
| VV806835A | In distribution | |
| VE820003 | In distribution | |
| VV621111CE | In distribution | |
| VE201712 | In distribution | |
| VE655526 | In distribution | |
| VE655535 | In distribution | |
| VV603220 | Needle Gauge 20 G | In distribution |
| VV800735 | Needle Gauge 20 G | In distribution |
| VV621011DE | In distribution | |
| VC821100 | In distribution | |
| VE655435 | In distribution | |
| VV603207 | Needle Gauge 20 G | In distribution |
| VV603231 | In distribution | |
| VV106010 | Needle Gauge 23 G | In distribution |
| VV621011DEC | In distribution | |
| VV621011DB | In distribution | |
| VG800011 | In distribution | |
| VE655000 | In distribution | |
| VE655035 | In distribution | |
| VV106110 | Needle Gauge 23 G | In distribution |
| VC840100 | In distribution | |
| VV603208 | In distribution | |
| VE821015 | In distribution | |
| VV603209 | Needle Gauge 19 G | In distribution |
| VE201710 | In distribution | |
| VV806833 | In distribution | |
| VE655525 | In distribution | |
| VE904705 | In distribution | |
| VV806840 | In distribution | |
| VE201722 | In distribution | |
| VV803100 | In distribution | |
| VE655235 | In distribution | |
| VE655527 | In distribution | |
| VE820006 | In distribution | |
| VV621111CE2 | In distribution | |
| VV800735A | In distribution | |
| VV603206 | Needle Gauge 19 G | In distribution |
| VV806835B | In distribution | |
| VV806834 | Needle Gauge 19 G | In distribution |
| VE850003 | Withdrawn | |
| VV800833 | Withdrawn | |
| VE820002 | Withdrawn | |
| VE655015 | Withdrawn | |
| VV104110 | Needle Gauge 20 G | Withdrawn |
| VV105010 | Needle Gauge 25 G | Withdrawn |
| VV800740 | Withdrawn | |
| VV104010 | Needle Gauge 20 G | Withdrawn |
| VE655515 | Withdrawn | |
| VV800735B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 109 |
| Alcon | Alcon Laboratories, Inc. | 95 |
| Laminar | Johnson & Johnson Surgical Vision, Inc. | 40 |
| Engauge | Alcon Laboratories, Inc. | 18 |
| Unity | Alcon Laboratories, Inc. | 18 |
| Constellation | Alcon Laboratories, Inc. | 16 |
| MST/Packard A1.7mm Phaco Tip Bent Dewey 30° | Microsurgical Technology, Inc. | 11 |
| Whitestar Signature | Johnson & Johnson Surgical Vision, Inc. | 10 |
| Alcon, Infiniti, MicroSmooth, ABS | Alcon Laboratories, Inc. | 10 |
| Compact Intuitiv | Johnson & Johnson Surgical Vision, Inc. | 9 |
| Alcon, Infiniti, Intrepid | Alcon Laboratories, Inc. | 9 |
| MST.7mm A1 Bent Phaco Tip 45° | Microsurgical Technology, Inc. | 8 |
Showing 12 of 619. All products under Unit, Phacofragmentation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233398 | 2024-06-27 |
| K133562 | 2014-08-12 |
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.