OR Head Holder LUCY with HeadCoilSet Philips 1.5T

Basic Information

• Brand Name: OR Head Holder LUCY with HeadCoilSet Philips 1.5T
• Primary DI: 04251269207303
• Version / Model: 02
• Catalog Number: 120281
• Company Name: Noras MRI products GmbH
• Labeler DUNS: 312844095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-11
• Public Version: 1
• Public Version Date: 2023-05-19
• Public Version Status: New
• Public Device Record Key: a9f204e8-5210-4b77-8a07-f96952b00535

Device Description

The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery. The OR Head Holder LUCY is used for safe securing the patient’s head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging, in the X-ray environment it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
MOS	Coil, Magnetic Resonance, Specialty	Radiology	892.1000	2
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	882.4460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40749	MRI system coil, radio-frequency	A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251269207303	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211658	000