WaveWriter Alpha™ 16
GUDID 08714729985082
Implantable Pulse Generator Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Analgesic spinal cord electrical stimulation system pulse generator, implantable| Primary Device ID | 08714729985082 |
| NIH Device Record Key | bb317a82-d773-453e-850c-905dac1fef62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WaveWriter Alpha™ 16 |
| Version Model Number | SC-1216 |
| Company DUNS | 824951958 |
| Company Name | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729985082 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P030017
FDA Product Code
| LGW | Stimulator, spinal-cord, totally implanted for pain relief |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-05 |
| Device Publish Date | 2020-12-28 |
Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
| 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 |
| 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 |
Trademark Results [WaveWriter Alpha]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WAVEWRITER ALPHA 88456779 not registered Live/Pending |
Boston Scientific Neuromodulation Corporation 2019-06-03 |
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