Identity
- Trade Name
- Vercise™ Cartesia™ FDA UDI
- Generic Name
- Deep brain electrical stimulation system FDA UDI
- Device Name
- 30cm 8 Contact DBS Directional Lead Kit FDA UDI
- Model / Reference
- DB-2202-30 FDA UDI
- Description
- 30cm 8 Contact DBS Directional Lead Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729905271 FDA UDI
- PMA Number
- P150031 FDA UDI
- FDA Product Code
- NHL FDA UDIPJS FDA UDIMHY FDA UDI
- GMDN Term
- Deep brain electrical stimulation system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Deep brain electrical stimulation system
Vercise™ Cartesia™ by Boston Scientific Neuromodulation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Deep brain electrical stimulation system.
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- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
Cleared under the same submission
P150031 also covers:
- Bionic Navigator ™ — Boston Scientific Neuromodulation
- Bionic Navigator™ — Boston Scientific Neuromodulation
- Precision Spectra ™ — Boston Scientific Neuromodulation
- SureTek™ — Boston Scientific Neuromodulation
- SureTek™ — Boston Scientific Neuromodulation
- Vercise Genus™ — Boston Scientific Neuromodulation
- Vercise Genus™ — Boston Scientific Neuromodulation
- Vercise Genus™ — Boston Scientific Neuromodulation
- Vercise Genus™ — Boston Scientific Neuromodulation
- Vercise Gevia™ — Boston Scientific Neuromodulation
- Vercise ™ — Boston Scientific Neuromodulation
- Vercise ™ — Boston Scientific Neuromodulation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Neuromodulation
Sources (1)
- FDA UDI 6a1663c8-edaf-4769-9a8f-7c6c4e9075f4 35 fields · synced May 30, 2026