OR Head Holder LUCY with HeadCoilSet Philips 3T 120282

GUDID 04251269205828

The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment. Together with the NORAS OR head coils 1.5T/3T the head holder LUCY is used for intra-operative MR imaging during neurosurgery on the open skull.

Noras MRI products GmbH

MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency

• Primary Device ID: 04251269205828
• NIH Device Record Key: 8d0d01a3-04aa-48d9-8e29-c9675db8b57e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OR Head Holder LUCY with HeadCoilSet Philips 3T
• Version Model Number: 01
• Catalog Number: 120282
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269205828 [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: 2022-05-26
• Device Publish Date: 2022-05-18

On-Brand Devices [OR Head Holder LUCY with HeadCoilSet Philips 3T]

• 04251269205828: The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment
• 04251269207310: The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction