ABC
ABC HANDPIECE 45° Footswitching Handpiece
1manufacturer
4catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | HAM |
| Device type | Apparatus, Electrosurgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2024-08-01 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 32 °C; Storage environment temperature 50 to 90 °F; Storage environment humidity 5 to 70 % RH |
| Packaging | Carton of 10, box of 10 |
| Distribution end date | 2023-10-11 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 130345 | 10 | In distribution | |
| 130500 | In distribution | ||
| 130321 | 10 | In distribution | |
| 130500 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ESI | FTT Medical, Inc. | 12 |
| Kirwan | Kirwan Surgical Products, LLC. | 10 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 5 |
| Weck | Teleflex Medical LLC | 3 |
| Conmed | ConMed Corporation | 2 |
| Pilling | Teleflex Medical LLC | 2 |
| Vivid Electrode Tip #6 | Pearson Dental Supplies, Inc. | 1 |
| ITL Essential Standard Quiver | ITL Asia Pacific SDN BHD | 1 |
| Vivid Electrode Tip #11 | Pearson Dental Supplies, Inc. | 1 |
| DLP® | Medtronic, Inc. | 1 |
| Vivid Electrode Tip #21 | Pearson Dental Supplies, Inc. | 1 |
| Vivid Electrode Tip #2 | Pearson Dental Supplies, Inc. | 1 |
Showing 12 of 22. All products under Apparatus, Electrosurgical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-12-27 | Class II | Equipment maintenance | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed tha | 313,190 (total for all devices) | 2018-05-14 |
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.