FDA UDI
In Commercial Distribution
🇺🇸 United States
gammaCore Sapphire
DI: 00815203022045
·
Model: 13016-04501-C
·
electroCore, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- gammaCore Sapphire
- Primary DI
- 00815203022045
- Version / Model
- 13016-04501-C
- Catalog Number
- 13016-04501-C
- Company Name
- electroCore, Inc.
- Labeler DUNS
- 831341628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-16
- Public Version
- 1
- Public Version Date
- 2026-02-24
- Public Version Status
- New
- Public Device Record Key
- 317ae1b9-99d1-4c6b-af10-3a8d6766f01b
Device Description
gammaCore Sapphire 31-Day Refill Card Only
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QAK | Non-Invasive Vagus Nerve Stimulator For Migraine Headache | Neurology | 882.5892 | 2 |
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache | Neurology | 882.5892 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58832 | Migraine-therapy peripheral nerve electrical stimulator | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815203022045 | GS1 |
Customer Contacts
- Phone
- 1-888-903-2673
- [email protected]