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Galaxy G3 GLX123505

by Cerenovus, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886704077657 UDI-DI Date16 Nov 2016ListedStatusListed 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  • Withdrawn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
Galaxy G3
Generic Name
Neurovascular embolization coil
Model / Ref / Catalog
GLX123505
Primary DI / UDI-DI
10886704077657
FDA Product Code
KRD, HCG
GMDN Term
Neurovascular embolization coil
Device Class
Class II
Regulation Number
870.3300, 882.5950
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Neurovascular embolization coil

Other devices from Cerenovus, Inc.

See all devices from Cerenovus, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No