Oval Loop Electrode
19/64" RND Loop Elec. 4"L REG WIRE,1/16"
2manufacturers in China registered for this device type
22catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Cynosure, LLC, United States |
|---|---|
| FDA product code | JOS |
| Device type | Electrode, Electrosurgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-19 |
| Record revised | 2023-01-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TB10B/4 | 2 | In distribution | |
| TP5B | 2 | In distribution | |
| TP4B | 2 | In distribution | |
| TP8B | 2 | In distribution | |
| TP9B | 2 | In distribution | |
| TP9B/4 | 2 | In distribution | |
| TB9B/4 | 2 | In distribution | |
| XPFB | 5 | In distribution | |
| TP6B | 2 | In distribution | |
| TP7B/4 | 2 | In distribution | |
| TP8B/4 | 2 | In distribution | |
| TP1B | 2 | In distribution | |
| TP3B/4 | 2 | In distribution | |
| TP4B/4 | 2 | In distribution | |
| XPRB | 5 | In distribution | |
| TP5B/4 | 2 | In distribution | |
| TP6B/4 | 2 | In distribution | |
| TP7B | 2 | In distribution | |
| TP10B | 2 | In distribution | |
| TP2B | 2 | In distribution | |
| XPRB/4 | 5 | In distribution | |
| TP3B | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Assi | Accurate Surgical & Scientific Instruments Corp. | 55 |
| Cameron-Miller | Cameron-Miller, Inc. | 34 |
| Kirwan | Kirwan Surgical Products, LLC. | 30 |
| Empire microIncision Needle Electrodes | Cynosure, LLC | 27 |
| Round Loop Electrode | Cynosure, LLC | 22 |
| Needle Electrode | Cynosure, LLC | 15 |
| Ball Electrode | Cynosure, LLC | 15 |
| Electrode, Electrosurgical | Richard Wolf Gmbh | 14 |
| Diamond Loop Electrode | Cynosure, LLC | 13 |
| Triangle Loop Electrode | Cynosure, LLC | 11 |
| Lletz Bayonet | Cynosure, LLC | 9 |
| Vari-TIP Wire Electrode | Cynosure, LLC | 8 |
Showing 12 of 138. All products under Electrode, Electrosurgical
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.