| 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 |
| 08714729950684 - Entrada ™ | 2025-08-25 Needle 11cm (4.5in) |
| 08714729950691 - Entrada ™ | 2025-08-25 Needle 15cm (6.0 in) |
| 08714729950707 - Entrada ™ | 2025-08-25 Spare Sheath 11cm (4.5 in) |
| 08714729950714 - Entrada ™ | 2025-08-25 Spare Sheath 15cm (6.0 in) |
| 08714729952053 - Freelink™ | 2025-08-25 Remote Control |
| 08714729953449 - Freelink™ | 2025-08-25 Remote Control Kit |
| 08714729953487 - Bionic Navigator™ 3D | 2025-08-25 BN 3D 2.0 Installer |
| 08714729820758 - Vercise™ | 2025-08-12 Implantable Pulse Generator Kit |