Base Plate LUCY Maquet 119024

GUDID 04251269204098

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

• Primary Device ID: 04251269204098
• NIH Device Record Key: 89ba61f7-453e-41a3-b029-75cbdc6d7c3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Base Plate LUCY Maquet
• Version Model Number: 01
• Catalog Number: 119024
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	04251269204098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211658

FDA Product Code

• HBL: Holder, Head, Neurosurgical (Skull Clamp)

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: 2022-05-25
• Device Publish Date: 2022-05-17

Devices Manufactured by Noras MRI products GmbH

• 04251269207297 - iLoop Interventional Coil 0.55T: 2024-06-19 The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination
• 04251269207341 - Breast BI 7 MR Coil Set 1.5T: 2023-09-18 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207358 - Breast BI 7 MR Coil Set 3T: 2023-09-18 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207334 - Breast BI 7 MR Coil Set 1.5T: 2023-07-24 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207327 - Breast BI 7 MR Coil Set 3T: 2023-05-30 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207303 - OR Head Holder LUCY with HeadCoilSet Philips 1.5T: 2023-05-19 The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scann
• 04251269207310 - OR Head Holder LUCY with HeadCoilSet Philips 3T: 2023-05-19 The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scann
• 04251269203022 - Uni-Lift – Base Unit: 2022-07-14 The Uni-Lift is used for aiding MR guided prostate interventions such as prostate biopsy or therapy.