MST/Packard.7mm Straight PT Dwy 30°
MST/Packard .7mm straight PT Dwy 30° Single Use
4manufacturers in China registered for this device type
3catalogue 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 | Microsurgical Technology, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K943672 |
| Record published | 2016-12-08 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PT-32430-1 | In distribution | |
| PT-32430-1 | In distribution | |
| PT-32430 | 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 |
|---|---|
| K953959 | 1995-11-17 |
| K943672 | 1994-10-13 |
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.