Breast BI 7 MR Coil Set 3T 118890

GUDID 04251269204418

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269204418
• NIH Device Record Key: 22808dfb-3603-4d28-88c5-7df3f6f4e1a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breast BI 7 MR Coil Set 3T
• Version Model Number: 03
• Catalog Number: 118890
• 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: true
• 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: 0049299270
• Email: sales@noras.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269204418 [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: 2018-07-13

On-Brand Devices [Breast BI 7 MR Coil Set 3T]

• 04251269205491: 04
• 04251269204418: 03
• 04251269203381: 02
• 04251269202643: 01
• 04251269205972: 06
• 04251269205590: 05
• 04251269206986: The intended use of the Breast BI 7 MR Coil Set 3T is, in conjunction with a Magnetic Resonance
• 04251269207327: The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR
• 04251269207358: The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR