iLoop Interventional Coil 0.55T 121048

GUDID 04251269207297

The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body.

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269207297
• NIH Device Record Key: 5fbc9a4b-0dd7-4806-beb5-f84de4e6b572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLoop Interventional Coil 0.55T
• Version Model Number: 01
• Catalog Number: 121048
• 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
• Phone: +49931299270
• Email: sales@noras.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269207297 [Primary]

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: 2024-06-19
• Device Publish Date: 2024-06-11

Devices Manufactured by Noras MRI products GmbH

• 04251269207365 - Breast BI 7 MR Coil Set 1.5T: 2025-03-19 The intended use of Breast BI 7 MR Coil Set 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the
• 04251269207372 - Breast BI 7 MR Coil 1.5T: 2025-03-19 The intended use of Breast BI 7 MR Coil Set 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the
• 04251269207297 - iLoop Interventional Coil 0.55T: 2024-06-19The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body.
• 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