Kirwan
Disposable Tungsten Micro Dissection Needle Kit (Packaged in Clamshell Tray)
2manufacturers in China registered for this device type
30catalogue 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 | Kirwan Surgical Products, LLC., United States |
|---|---|
| FDA product code | JOS |
| Device type | Electrode, Electrosurgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K895331 |
| Record published | 2018-05-18 |
| Record revised | 2022-01-31 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 4, pack of 5 |
| Sizes | Length 1.25 to 15 in; length 25 to 30.2 cm |
| Distribution end date | 2018-09-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-8006 | Length 1.63 in | In distribution |
| 30-8017 | Length 4.88 in | In distribution |
| 30-8015 | Length 4 in | In distribution |
| 30-8012 | Length 4.5 in | In distribution |
| 30-8000-KIT | In distribution | |
| 30-6011 | Length 30.2 cm | In distribution |
| 30-8013 | Length 6.625 in | In distribution |
| 30-8000 | Length 1.25 in | In distribution |
| 30-8008 | Length 2 in | In distribution |
| 30-8007 | Length 1.63 in | In distribution |
| 30-8014 | Length 6.5 in | In distribution |
| 30-6020 | Length 25 cm | In distribution |
| 30-6021 | In distribution | |
| 30-6012 | Length 30.2 cm | In distribution |
| 30-8004 | Length 5.5 in | In distribution |
| 30-6022 | Length 25 cm | In distribution |
| 30-6002 | Length 15 in | In distribution |
| 30-8016 | Length 5.875 in | In distribution |
| 30-8009 | Length 2 in | In distribution |
| 30-6004 | Length 15 in | In distribution |
| 30-8018 | Length 6.875 in | In distribution |
| 30-6003S | In distribution | |
| 30-6001 | Length 15 in | In distribution |
| 30-8011 | Length 4.63 in | In distribution |
| 30-8002 | Length 2 in | In distribution |
| 30-6003 | Length 15 in | In distribution |
| 30-8010 | Length 2.5 in | In distribution |
| 30-6022 | Withdrawn | |
| 30-6011 | Length 30.2 cm | Withdrawn |
| 30-6012 | Length 30.2 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Assi | Accurate Surgical & Scientific Instruments Corp. | 55 |
| Cameron-Miller | Cameron-Miller, Inc. | 34 |
| Empire microIncision Needle Electrodes | Cynosure, LLC | 27 |
| Round Loop Electrode | Cynosure, LLC | 22 |
| Oval 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.