← Back to catalogue

gammaCore Refill Card 10-Day

FDA UDI

Class II (US FDA UDI)

by ElectroCore, Inc.

Identity

Trade Name
gammaCore Refill Card 10-Day FDA UDI
Generic Name
Migraine-therapy peripheral nerve electrical stimulator FDA UDI
Device Name
Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a "gammaCore Refill Card" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away. FDA UDI
Model / Reference
10016-43110 FDA UDI
Description
Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a "gammaCore Refill Card" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away. FDA UDI

Identifiers

Catalog Number
10016-43110 FDA UDI
Primary DI / UDI-DI
00815203020041 FDA UDI
FDA Product Code
PKR FDA UDI
QAK 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 Refill Card 10-Day 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

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

Manufacturer

Manufacturer
ElectroCore, Inc.

Sources (1)

  • FDA UDI 35c15168-1cd2-4d10-b089-815a6f66bd26 36 fields · synced May 30, 2026