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SetPoint Charger

FDA UDI

Class III (US FDA UDI)

by SetPoint Medical

Identity

Trade Name
SetPoint Charger FDA UDI
Generic Name
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Model / Reference
E04 FDA UDI

Identifiers

Primary DI / UDI-DI
00860013950224 FDA UDI
PMA Number
P240039 FDA UDI
FDA Product Code
SFJ 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

SetPoint Charger by SetPoint Medical — 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

P240039 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SetPoint Medical

Sources (1)

  • FDA UDI f3505fd3-4c4c-4f0c-af91-7c8d54afcf0e 33 fields · synced May 30, 2026