Primary Device ID | 00813250017229 |
NIH Device Record Key | d5e7ebbf-2f1c-48e0-847c-860b3af2d41f |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | C103-RTM |
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 | true |
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 | 00813250017229 [Primary] |
GXD | GENERATOR, LESION, RADIOFREQUENCY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-10-08 |
Device Publish Date | 2017-08-21 |
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 |