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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 11016-40303 is programmed to deliver 24 doses per day for 12 months (1 year). 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
11016-40303 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 11016-40303 is programmed to deliver 24 doses per day for 12 months (1 year). 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
11016-40303 FDA UDI
Primary DI / UDI-DI
00815203020447 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 77909f43-c7ab-4c61-9dc6-836522168a7c 36 fields · synced Jun 6, 2026