IRR & ASP Handpieces Bimanual Front
Catalogue number 303060-0166-000, listed by Carl Zeiss Meditec Inc, United States, under Unit, Phacofragmentation. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
3510(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 | Carl Zeiss Meditec Inc, United States |
|---|---|
| FDA product code | HQC |
| Device type | Unit, Phacofragmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4670 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2022-04-25 |
| Record revised | 2024-01-31 (version 2) |
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 | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 303060-0166-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 109 |
| Alcon | Alcon Laboratories, Inc. | 95 |
| Oertli® | Oertli Instrumente AG | 66 |
| 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 |
Showing 12 of 619. All products under Unit, Phacofragmentation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230858 | 2023-07-31 |
| K212241 | 2022-04-19 |
| K193376 | 2020-06-15 |
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.