Catalogue number PT-32330-B, listed by Microsurgical Technology, Inc., United States, under Unit, Phacofragmentation. 4 manufacturers in China are registered for 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.
Record
Regulatory record for MST/Packard.7mm strt p tp 30º | 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 | 2016-11-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Radiation Sterilization, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
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.