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Vercise ™

FDA UDI

Class III (US FDA UDI)

by Boston Scientific Neuromodulation

Identity

Trade Name
Vercise ™ FDA UDI
Generic Name
Deep brain electrical stimulation system FDA UDI
Device Name
Neural Navigator 5 FDA UDI
Model / Reference
DB-7105-N5 FDA UDI
Description
Neural Navigator 5 FDA UDI

Identifiers

Primary DI / UDI-DI
00191506023218 FDA UDI
PMA Number
P150031 FDA UDI
FDA Product Code
MHY FDA UDI
PJS FDA UDI
NHL 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.

Cleared under the same submission

P150031 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific Neuromodulation

Sources (1)

  • FDA UDI e3f51eb0-cbb9-4495-9966-98ca0a2b43cd 34 fields · synced Jun 1, 2026