Identity
- Trade Name
- Vercise ™ FDA UDI
- Generic Name
- Deep brain electrical stimulation system FDA UDI
- Device Name
- Neural Navigator 3.1 Installer FDA UDI
- Model / Reference
- DB-7105-N31-W10 FDA UDI
- Description
- Neural Navigator 3.1 Installer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729994909 FDA UDI
- PMA Number
- P150031 FDA UDI
- FDA Product Code
- PJS FDA UDIMHY FDA UDINHL 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Deep brain electrical stimulation system
Vercise ™ by Boston Scientific Neuromodulation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Deep brain electrical stimulation system.
- Percept™ PC BrainSense™ — MEDTRONIC, INC. · Class III
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- SenSight™ — MEDTRONIC, INC. · Class III
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific Neuromodulation
Sources (1)
- FDA UDI 14d21a75-9966-4b91-838b-b0df3e1b85f4 34 fields · synced Jun 8, 2026