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Galeo EW

by Concert Medical, LLC

Galeo EW (406890) is a Class II device made by Concert Medical, LLC, listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00814384020093), registry data as of 8 Jun 2026.

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

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814384020093 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Coronary artery guidewire extension
Model / Ref / Catalog
EW, 406890
Primary DI / UDI-DI
00814384020093
FDA product code
DQX
GMDN term
Coronary artery guidewire extension
Device class
Class II
Regulation number
870.1330
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DQX (Wire, Guide, Catheter).

Other devices from Concert Medical, LLC

See all devices from Concert Medical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)