OR Head Holder LUCY with HeadCoilSet Philips 1.5T 120281

GUDID 04251269207303

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.

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269207303
• NIH Device Record Key: a9f204e8-5210-4b77-8a07-f96952b00535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OR Head Holder LUCY with HeadCoilSet Philips 1.5T
• Version Model Number: 02
• Catalog Number: 120281
• Company DUNS: 312844095
• Company Name: Noras MRI products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de
• Phone: +49931299270
• Email: sales@noras.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269207303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211658

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-19
• Device Publish Date: 2023-05-11

On-Brand Devices [OR Head Holder LUCY with HeadCoilSet Philips 1.5T]

• 04251269205811: The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment
• 04251269207303: The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction