Frame Carrier Breast BI 7 meidal 120173

GUDID 04251269205637

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269205637
• NIH Device Record Key: 631e0d9f-b8f9-4629-be65-9f23e593b3dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Frame Carrier Breast BI 7 meidal
• Version Model Number: 01
• Catalog Number: 120173
• Company DUNS: 312844095
• Company Name: Noras MRI products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de
• Phone: +499312992714
• Email: sales@noras.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269205637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162651

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-06-30

Devices Manufactured by Noras MRI products GmbH

• 04251269207389 - Breast BI 7 MR Coil Set 3T: 2025-04-17 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207402 - iLoop Interventional Coil 0.55T: 2025-04-17 The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination
• 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: 2024-06-19 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