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Galeo EW

FDA UDI

Class II (US FDA UDI)

by Concert Medical, Llc

Identity

Trade Name
Galeo EW FDA UDI
Generic Name
Coronary artery guidewire extension FDA UDI
Device Name
Extension Guidewire FDA UDI
Model / Reference
EW FDA UDI
Description
Extension Guidewire FDA UDI

Identifiers

Catalog Number
406890 FDA UDI
Primary DI / UDI-DI
00814384020093 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Coronary artery guidewire extension FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coronary artery guidewire extension

Galeo EW by Concert Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary artery guidewire extension.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Concert Medical, Llc

Sources (1)

  • FDA UDI 67d3e854-23d7-4f16-adb8-14ca541beb97 35 fields · synced Jun 8, 2026