| Primary Device ID | 00191506023584 |
| NIH Device Record Key | 61189f76-c1a5-40cd-9061-c0cbf007c5f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DB-3128-95B |
| 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 |
| Length | 95 Centimeter |
| Length | 95 Centimeter |
| Length | 95 Centimeter |
| Length | 95 Centimeter |
| Length | 95 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506023584 [Primary] |
| NHL | Stimulator, electrical, implanted, for parkinsonian symptoms |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-08 |
| Device Publish Date | 2022-10-31 |
| 08714729121688 - Precision ™ | 2024-03-25 Adhesive Kit |
| 08714729121435 - Precision™ | 2024-03-19 Hex Wrench |
| 08714729121442 - NA | 2024-03-19 10cm (4 Inch) Insertion Needle |
| 08714729121459 - NA | 2024-03-19 13cm (5 Inch) Insertion Needle |
| 08714729121497 - NA | 2024-03-19 Stylet Kit with Stylet Cap 30cm |
| 08714729121503 - NA | 2024-03-19 Stylet Kit with Stylet Cap 50cm |
| 08714729121510 - NA | 2024-03-19 Stylet Kit with Stylet Cap 70cm |
| 08714729121558 - NA | 2024-03-19 Enhanced Steering Kit with Stylet Cap 30cm |