gammaCore 20016-00003-RPL

GUDID 00815203022441

Replacement Device Protective Cap, Clear

electroCore, Inc.

Migraine-therapy peripheral nerve electrical stimulator
Primary Device ID00815203022441
NIH Device Record Key58d6bbf6-42ec-4b34-bf95-2013f4ae6452
Commercial Distribution StatusIn Commercial Distribution
Brand NamegammaCore
Version Model Number20016-00003-RPL
Catalog Number20016-00003-RPL
Company DUNS831341628
Company NameelectroCore, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815203022441 [Primary]

FDA Product Code

PKRNon-Invasive Vagus Nerve Stimulator - Headache

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-24
Device Publish Date2026-02-16

On-Brand Devices [gammaCore]

00815203022458gammaCore Replacement Product Box Assembly, 5 Pack
00815203022441Replacement Device Protective Cap, Clear

Trademark Results [gammaCore]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GAMMACORE
GAMMACORE
85214940 4092205 Live/Registered
ElectroCore LLC
2011-01-11

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.