NORAS OR HEAD COIL Top Array Siemens 3T 112893

GUDID 04251269205897

The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Noras MRI products GmbH

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• Primary Device ID: 04251269205897
• NIH Device Record Key: 26dc5859-2fb9-4f5a-9a48-084c03c175cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NORAS OR HEAD COIL Top Array Siemens 3T
• Version Model Number: 04
• Catalog Number: 112893
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251269205897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091546

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-28
• Device Publish Date: 2020-08-20

On-Brand Devices [NORAS OR HEAD COIL Top Array Siemens 3T]

• 04251269202605: 03
• 04251269205897: The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner,
• 04251269206795: The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner,