NA
- Primary DI
- 00813250014839
- Brand
- NA
- Company
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Model
- C110
- Device description
- Active Cable, CR Needles for Neurotherm
- Published
- 2017-08-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| GXD | GENERATOR, LESION, RADIOFREQUENCY |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GXD | Generator, Lesion, Radiofrequency | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00813250014839 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00813250014839 | 00813250014839 | 813250014839 | 0813250014839 |
GMDN Terms
| Term | Definition |
|---|
| Radio-frequency ablation system | An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s). |
Regulatory Flags
- DUNS number
- 824951958
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00191506048518 | GX1™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | GXD | 2025-09-29 |
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| 00191506059309 | GX1™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | GXD | 2025-09-29 |
| 00191506059330 | GX1™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | GXD | 2025-09-29 |
| 00191506059347 | GX1™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | GXD | 2025-09-29 |
| 00191506059354 | GX1™ | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | GXD | 2025-09-29 |
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| 00856895008559 | OneRF Ablation System | NEUROONE MEDICAL TECHNOLOGIES CORPORATION | GXD | 2024-03-15 |
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| 00193493473021 | COOLIEF* | Avanos Medical, Inc. | GXD | 2021-01-27 |
| 00193493473038 | COOLIEF* | Avanos Medical, Inc. | GXD | 2021-01-27 |
| 05415067029317 | IonicRF™ | ST. JUDE MEDICAL, INC. | GXD | 2020-12-14 |
| 05415067033833 | IonicRF™ | ST. JUDE MEDICAL, INC. | GXD | 2020-12-11 |
| 00193493473014 | AVANOS | Avanos Medical, Inc. | GXD | 2020-10-16 |
| 00193493473052 | AVANOS | Avanos Medical, Inc. | GXD | 2020-10-16 |