| Primary Device ID | 00815871020077 |
| NIH Device Record Key | 9efcb83b-f1d6-4b8c-be07-a36a4cf9d5f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra SL |
| Version Model Number | 00104 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| Phone | 502-244-4444 |
| devicehelp@dremed.com | |
| 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 | 00815871020077 [Primary] |
| BSZ | Gas-Machine, Anesthesia |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-19 |
| Device Publish Date | 2015-12-23 |
| 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 |