| Primary Device ID | 00813250017588 |
| NIH Device Record Key | f3a857c1-a32e-426a-965a-0e575099eb78 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | GTRT-16-76 |
| Company DUNS | 824951958 |
| Company Name | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813250017588 [Primary] |
| GXD | GENERATOR, LESION, RADIOFREQUENCY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2017-08-21 |
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| 08714729966357 - Vercise™ Cartesia™ HX | 2024-12-23 Directional Lead Kit, 16 Contact, 30cm |
| 08714729966364 - Vercise™ Cartesia™ HX | 2024-12-23 Directional Lead Kit, 16 Contact, 45cm |
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| 08714729966388 - NA | 2024-12-23 Lead Extension Kit, 2x8 Contact, 95cm |
| 08714729966395 - NA | 2024-12-23 16 Contact Lead Extension Kit, 55 cm |
| 08714729966401 - NA | 2024-12-23 16 Contact Lead Extension Kit, 95 cm |