← Back to catalogue

Vivistim®

FDA UDI

Class III (US FDA UDI)

by Microtransponder

Identity

Trade Name
Vivistim® FDA UDI
Generic Name
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Device Name
Implantable Pulse Generator FDA UDI
Model / Reference
1001 FDA UDI
Description
Implantable Pulse Generator FDA UDI

Identifiers

Primary DI / UDI-DI
10810041430028 FDA UDI
PMA Number
P210007 FDA UDI
FDA Product Code
QPY FDA UDI
GMDN Term
Antiseizure/psychiatric-therapy vagus nerve implantable 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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

Vivistim® by Microtransponder — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system.

Cleared under the same submission

P210007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Microtransponder

Sources (1)

  • FDA UDI 9c182b84-42b5-46a1-ae42-d913514c2678 34 fields · synced May 31, 2026