| Primary Device ID | 00815871020091 |
| NIH Device Record Key | e4cd08a1-0a54-4503-8f40-329d4f43fc49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Monopolar Handswitching Pencil |
| Version Model Number | P00507 |
| Company DUNS | 178440426 |
| Company Name | Avante |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815871020091 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-02 |
| Device Publish Date | 2016-09-23 |
| 00815871020091 - Disposable Monopolar Handswitching Pencil | 2020-03-02 |
| 00815871020091 - Disposable Monopolar Handswitching Pencil | 2020-03-02 |
| 00815871020190 - Compact FM | 2020-03-02 |
| 00815871020206 - Compact FM | 2020-03-02 |
| 00815871020213 - Compact FM | 2020-03-02 |
| 00815871020220 - Compact FM | 2020-03-02 |
| 00815871020237 - Compact Plus | 2020-03-02 |
| 00815871020244 - Compact Plus | 2020-03-02 |
| 00815871020251 - Compact Plus | 2020-03-02 |