| Primary Device ID | 08714729931751 |
| NIH Device Record Key | 87c3bdca-cd90-403a-a491-618e5a9ff324 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DB-4320 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729931751 [Primary] |
| NHL | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-10-29 |
| Device Publish Date | 2017-12-12 |
| 00191506047276 - Vercise ™ DBS | 2025-03-04 Controller |
| 00191506047283 - Vercise ™ DBS | 2025-03-04 Controller Patient Kit |
| 00191506047290 - Vercise ™ DBS | 2025-03-04 Controller Clinician Kit |
| 08714729966333 - Vercise™ Cartesia™ X | 2024-12-23 Directional Lead Kit, 16 Contact, 30cm |
| 08714729966340 - Vercise™ Cartesia™ X | 2024-12-23 Directional Lead Kit, 16 Contact, 45cm |
| 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 |
| 08714729966371 - NA | 2024-12-23 Lead Extension Kit, 2x8 Contact, 55cm |