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gammaCore Sapphire D

FDA UDI

Class II (US FDA UDI)

by ElectroCore, Inc.

Identity

Trade Name
gammaCore Sapphire D FDA UDI
Generic Name
Migraine-therapy peripheral nerve electrical stimulator FDA UDI
Device Name
gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40302 is programmed to deliver 24 doses per day for 6 months. Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device. FDA UDI
Model / Reference
11016-40302 FDA UDI
Description
gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40302 is programmed to deliver 24 doses per day for 6 months. Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device. FDA UDI

Identifiers

Catalog Number
11016-40302 FDA UDI
Primary DI / UDI-DI
00815203020430 FDA UDI
FDA Product Code
QAK FDA UDI
PKR FDA UDI
GMDN Term
Migraine-therapy peripheral nerve electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5892 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Migraine-therapy peripheral nerve electrical stimulator

gammaCore Sapphire D by ElectroCore, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Migraine-therapy peripheral nerve electrical stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ElectroCore, Inc.

Sources (1)

  • FDA UDI ab2135bb-f5c6-4065-baa5-76e84b09a2e1 36 fields · synced May 31, 2026