FDA.reportPublic FDA data

gammaCore Sapphire

Primary DI
00815203022236
Brand
gammaCore Sapphire
Company
electroCore, Inc.
Model
12016-04999
Catalog number
12016-04999
Device description
gammaCore Sapphire EVAL
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKRNon-Invasive Vagus Nerve Stimulator - Headache
QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKRNon-Invasive Vagus Nerve Stimulator - HeadacheNeurology2
QAKNon-Invasive Vagus Nerve Stimulator For Migraine HeadacheNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815203022236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815203022236008152030222368152030222360815203022236

GMDN Terms#

Term, Definition table
TermDefinition
Migraine-therapy peripheral nerve electrical stimulatorA portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls, user display, and metal skin contact surfaces that enable application of the electrical signal intended to provide a localized oscillating electric field; it may be used in conjunction with a smartphone. The device is typically used with conductive gel and may be operated by a patient or healthcare provider in the home and healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-903-2673customerservice@electrocore.com

Regulatory Flags#

DUNS number
831341628
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815203020089gammaCore Sapphire20016-00301-RPL20016-00301-RPL2026-02-16
00815203021864gammaCore Sapphire20016-00501-RPL20016-00501-RPL2026-02-16
00815203022045gammaCore Sapphire 13016-04501-C13016-04501-C2026-02-16
00815203022052gammaCore Sapphire13016-04502-C13016-04502-C2026-02-16
00815203022076gammaCore Sapphire13016-04504-C13016-04504-C2026-02-16
00815203022441gammaCore20016-00003-RPL20016-00003-RPL2026-02-16
00815203022458gammaCore20016-00006-RPL20016-00006-RPL2026-02-16
00815203022687gammaCore Sapphire20016-00502-RPL20016-00502-RPL2026-02-16
00815203022694gammaCore Emerald20116-00001-RPL20116-00001-RPL2026-02-16
00815203022700gammaCore Emerald20116-10301-RPL20116-10301-RPL2026-02-16
00815203022717gammaCore Emerald50022-00004-RPL50022-00004-RPL2026-02-16
00815203022724gammaCore Emerald50022-00078-RPL50022-00078-RPL2026-02-16
00815203022427gammaCore Sapphire AC Power Adapter20016-00001-RPL20016-00001-RPL2026-01-28
00815203022472gammaCore Emerald 3-Month Device Kit12116-0400312116-040032026-01-14
00815203022489gammaCore Emerald 12-Month Device Kit12116-0401212116-040122026-01-14
00815203022496gammaCore Emerald-D Device Kit12116-0403612116-040362026-01-14
00815203022502gammaCore Emerald 6-Month Evaluation Device Kit11116-0400611116-040062026-01-14
00815203022519gammaCore 1-Month Refill Kit12116-0450112116-045012026-01-14
00815203022526gammaCore 3-Month Refill Kit12116-0450312116-045032026-01-14
00815203022533gammaCore 12-Month Refill Kit12116-0451212116-045122026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815203020089gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203020089gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203021864gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203021864gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022045gammaCore Sapphire electroCore, Inc.QAK2026-02-16
00815203022045gammaCore Sapphire electroCore, Inc.PKR2026-02-16
00815203022052gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022052gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203022076gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022076gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203022441gammaCoreelectroCore, Inc.PKR2026-02-16
00815203022441gammaCoreelectroCore, Inc.QAK2026-02-16
00815203022458gammaCoreelectroCore, Inc.QAK2026-02-16
00815203022458gammaCoreelectroCore, Inc.PKR2026-02-16
00815203022687gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022687gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203022694gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022694gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022700gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022700gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022717gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022717gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022724gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022724gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022427gammaCore Sapphire AC Power AdapterelectroCore, Inc.QAK2026-01-28
00815203022427gammaCore Sapphire AC Power AdapterelectroCore, Inc.PKR2026-01-28
00815203022472gammaCore Emerald 3-Month Device KitelectroCore, Inc.QAK2026-01-14
00815203022472gammaCore Emerald 3-Month Device KitelectroCore, Inc.PKR2026-01-14
00815203022489gammaCore Emerald 12-Month Device KitelectroCore, Inc.QAK2026-01-14
00815203022489gammaCore Emerald 12-Month Device KitelectroCore, Inc.PKR2026-01-14