Identity
- Trade Name
- gammaCore Sapphire FDA UDI
- Generic Name
- Migraine-therapy peripheral nerve electrical stimulator FDA UDI
- Device Name
- gammaCore Sapphire, part number 10016-40302, 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. It can be programmed to deliver up to 30 doses per day for 31 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via a "Refill Card" encoded and provided by electroCore or its authorized agent. (Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.) The Refill Card will be provided to the user / patient requesting a refill of their device, 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. 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
- 10016-40302 FDA UDI
- Description
- gammaCore Sapphire, part number 10016-40302, 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. It can be programmed to deliver up to 30 doses per day for 31 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via a "Refill Card" encoded and provided by electroCore or its authorized agent. (Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.) The Refill Card will be provided to the user / patient requesting a refill of their device, 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. 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
- 10016-40302 FDA UDI
- Primary DI / UDI-DI
- 00815203020034 FDA UDI
- FDA Product Code
- PKR FDA UDIQAK 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
MR Unsafe FDA UDI
Category: Migraine-therapy peripheral nerve electrical stimulator
gammaCore Sapphire by ElectroCore, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ElectroCore, Inc.
Sources (1)
- FDA UDI ad98eb04-5b6a-4545-9cb0-9c6fd6258c98 36 fields · synced May 30, 2026