Navigation System Adapter LUCY 01

by NORAS MRI products GmbH GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04251269204289 UDI-DI	Date18 May 2022Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name: Navigation System Adapter LUCY
Generic Name: MRI system coil, radio-frequency
Model / Ref / Catalog: 01, 119668

Primary DI / UDI-DI: 04251269204289
510(k) Number: K211658
FDA Product Code: HBL
GMDN Term: MRI system coil, radio-frequency

Device Class: Class II
Regulation Number: 882.4460
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No