4 CH BI Breast MR Coil Kit 3T 113113

GUDID 04251269200175

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269200175
• NIH Device Record Key: 8dc461f4-1b6e-4a0d-8249-597d06873c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4 CH BI Breast MR Coil Kit 3T
• Version Model Number: 01
• Catalog Number: 113113
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +490931299270
• Email: sales@noras.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269200175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082373

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: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-08-11

On-Brand Devices [4 CH BI Breast MR Coil Kit 3T]

• 04251269205286: 06
• 04251269200175: 01