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SetPoint Implant

FDA UDI

Class III (US FDA UDI)

by SetPoint Medical

Identity

Trade Name
SetPoint Implant FDA UDI
Generic Name
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Model / Reference
M01 FDA UDI

Identifiers

Primary DI / UDI-DI
00860013950200 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

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

SetPoint Implant 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 c5a23fd9-9d04-4e67-9df2-59886fc62bb8 33 fields · synced May 30, 2026