FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00813250017519
·
Model: TCN-15-3M
·
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00813250017519
- Version / Model
- TCN-15-3M
- Company Name
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Labeler DUNS
- 824951958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-21
- Public Version
- 4
- Public Version Date
- 2022-03-17
- Public Version Status
- Update
- Public Device Record Key
- 9449fcf3-6d9a-46d7-a268-08b8dbfc0fcc
Device Description
Nitinol TC Electrode, 15cm, 3m Cable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXD | GENERATOR, LESION, RADIOFREQUENCY | Neurology | 882.4400 | 2 |
| GXI | PROBE, RADIOFREQUENCY LESION | Neurology | 882.4725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57972 | 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). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813250017519 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 15 cm Length | ||
| Device Size Text, specify | 3 m Length |