Cushion Breast 112297

GUDID 04251269205200

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269205200
• NIH Device Record Key: a97753ea-d2ea-4806-afb3-f1c9da64bf03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cushion Breast
• Version Model Number: 03
• Catalog Number: 112297
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269205200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081118

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: 2018-10-24

On-Brand Devices [Cushion Breast]

• 04251269205200: 03
• 04251269200205: 01