Primary Device ID | 00815203020423 |
NIH Device Record Key | 3c9ae2a5-eb87-4a19-a9ce-3038c1b46e15 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | gammaCore Sapphire 3 |
Version Model Number | 11016-40301 |
Catalog Number | 11016-40301 |
Company DUNS | 831341628 |
Company Name | ELECTROCORE, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-888-903-2673 |
customerservice@electrocore.com |
Special Storage Condition, Specify | Between 0 and 0 *Replace protective cover after use to protect the treatment surfaces from damage. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815203020423 [Primary] |
QAK | Non-Invasive Vagus Nerve Stimulator For Migraine Headache |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-10-23 |
Device Publish Date | 2019-10-14 |
00815203020539 - gammaCore Sapphire SLC Device Kit | 2021-08-12 gammaCore Sapphire SLC 31-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute trea |
00815203020546 - gammaCore Sapphire SLC Device Kit | 2021-08-12 gammaCore Sapphire SLC 93-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute trea |
00815203020553 - gammaCore Sapphire SLC DEMO Device Kit | 2021-08-12 gammaCore Sapphire SLC 62-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the applicati |
00815203020560 - gammaCore Sapphire SLC DEMO Device Kit | 2021-08-12 gammaCore Sapphire SLC 93-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the applicati |
00815203020614 - gammaCore Sapphire SLC Refill Card Kit | 2021-08-12 gammaCore Sapphire SLC 31-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is inten |
00815203020621 - gammaCore Sapphire SLC Refill Card Kit | 2021-08-12 gammaCore Sapphire SLC 93-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is inten |
00815203021260 - gammaCore Sapphire Device Starter Kit | 2021-08-12 gammaCore Sapphire 93-Day Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck |
00815203021277 - gammaCore Sapphire Device Starter Kit | 2021-08-12 gammaCore Sapphire 6-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of nec |