Breast BI 7 MR Coil Set 1.5T 118984

GUDID 04251269207341

The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician.

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269207341
• NIH Device Record Key: 41ff9ab4-431f-43a3-89ec-55a417f68c43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breast BI 7 MR Coil Set 1.5T
• Version Model Number: 06
• Catalog Number: 118984
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269207341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220144

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: 2023-09-18
• Device Publish Date: 2023-09-08

On-Brand Devices [Breast BI 7 MR Coil Set 1.5T]

• 04251269202636: 01
• 04251269205965: 03
• 04251269206979: The intended use of the Breast BI 7 MR Coil Set 1.5T is, in conjunction with a Magnetic Resonanc
• 04251269207334: The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR
• 04251269207341: The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR