2 catalogue numbers from 20-HM-2000, listed by Summit Medical LLC, United States, under Unit, Cautery, Thermal, Battery-Powered. 2 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Summit Medical | Listed by | Summit Medical LLC, United States |
| FDA product code | HQP |
| Device type | Unit, Cautery, Thermal, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4115 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-04-15 |
| Record revised | 2021-08-23 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
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.