Skip to content

gammaCore Sapphire 13016-04501-C

by ElectroCore, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815203022045 UDI-DI Date16 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
gammaCore Sapphire
Generic Name
Migraine-therapy peripheral nerve electrical stimulator
Model / Ref / Catalog
13016-04501-C
Primary DI / UDI-DI
00815203022045
FDA Product Code
QAK, PKR
GMDN Term
Migraine-therapy peripheral nerve electrical stimulator
Device Class
Class II
Regulation Number
882.5892
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from ElectroCore, Inc.

See all devices from ElectroCore, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No