Grid Biopsy Unit single use medial Breast BI 7 121039

GUDID 04251269207037

The intended use of Breast BI 7 MR Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast.

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269207037
• NIH Device Record Key: 3fabd662-4940-4d7d-8050-4a87677b8b63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grid Biopsy Unit single use medial Breast BI 7
• Version Model Number: 01
• Catalog Number: 121039
• 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: true
• Lot Batch: false
• 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: +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	04251269207037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162651

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

[04251269207037]

Moist Heat or Steam Sterilization

[04251269207037]

Moist Heat or Steam Sterilization

[04251269207037]

Moist Heat or Steam Sterilization

[04251269207037]

Moist Heat or Steam Sterilization

[04251269207037]

Moist Heat or Steam Sterilization

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 [Grid Biopsy Unit single use medial Breast BI 7]

• 04251269207037: The intended use of Breast BI 7 MR Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance
• 04251269207020: The intended use of Breast BI 7 MR Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance