Primary Device ID | 00191506023577 |
NIH Device Record Key | 2274af90-9d90-46a9-8b0d-0b0c9c5e83e5 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | DB-3128-55B |
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 | 55 Centimeter |
Length | 55 Centimeter |
Length | 55 Centimeter |
Length | 55 Centimeter |
Length | 55 Centimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00191506023577 [Primary] |
PJS | Stimulator, electrical, implanted, for essential tremor |
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 |