Encompass™ MRI Head Coil, Mirror Holder 119878

GUDID 04251269207273

The Encompass™ 15 Channel Head Coil is intended to be used in conjunction with a Magnetic Resonance Scanner for the MR examination of the human brain just before, during, and at the end of brain surgery. The Encompass™ 15 Channel Head Coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Noras MRI products GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04251269207273
• NIH Device Record Key: aa3fee5c-c2bc-4983-b76a-06c0d1e6c66b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encompass™ MRI Head Coil, Mirror Holder
• Version Model Number: 01
• Catalog Number: 119878
• 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: 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
• 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	04251269207273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190668

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: 2022-07-14
• Device Publish Date: 2022-07-06

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• 04251269207372 - Breast BI 7 MR Coil 1.5T: 2025-03-19 The intended use of Breast BI 7 MR Coil Set 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the
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• 04251269207341 - Breast BI 7 MR Coil Set 1.5T: 2023-09-18 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
• 04251269207358 - Breast BI 7 MR Coil Set 3T: 2023-09-18 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
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