Primary Device ID | 08714729989288 |
NIH Device Record Key | d82c9c56-8f8b-4e75-8d9a-b69d43ff06b5 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | DB-6358-1BK |
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 | false |
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 Issuing Agency | Device ID |
---|---|
GS1 | 08714729989288 [Primary] |
NHL | Stimulator, electrical, implanted, for parkinsonian symptoms |
PJS | Stimulator, electrical, implanted, for essential tremor |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-02-05 |
Device Publish Date | 2021-01-28 |
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 |