DORO LUCENT® iMRI Transfer Collision Indicator

Basic Information

• Brand Name: DORO LUCENT® iMRI Transfer Collision Indicator
• Primary DI: 04250435529867
• Version / Model: 4003.413
• Company Name: Black Forest Medical GmbH
• Labeler DUNS: 313517922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-10
• Public Version: 4
• Public Version Date: 2026-02-02
• Public Version Status: Update
• Public Device Record Key: befb008a-c9b9-4d78-8dac-566df4f0687b

Device Description

DORO LUCENT® iMRI Transfer Collision Indicator 600 MAQUET Magnus, EU to GE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBM	Headrest, Neurosurgical	Neurology	882.4440	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58055	Operating/examination/treatment table headrest, reusable	A device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. It is available in various shapes and sizes and might include mechanisms to enable adjustments in relation to the table top. It does not include components intended for immobilization of the head (i.e., not a positioner). This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250435529867	GS1