Emeryglide EG18008901

by Nano4imaging GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04260461060036 UDI-DI	Date23 Jul 2026Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Emeryglide
Generic Name: Cardiac/peripheral vascular guidewire, single-use
Model / Reference: EG18008901

Primary DI / UDI-DI: 04260461060036
510(k) Number: K253262
FDA Product Code: DQX
GMDN Term: Cardiac/peripheral vascular guidewire, single-use

Device Class: Class II
Regulation Number: 870.1330
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Conditional

Size: Guidewire Diameter — 0.035 Inch
Guidewire Length — 180 Centimeter

Other devices from Nano4imaging GmbH

MR Wire Guide Wire Straight, MR Wire Guide Wire Angled

Class II
MRWire Guide Wire

Class II
EmeryGlide™ (EG18008901)

Class II

Properties

Sterile
Single Use
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

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