Encompass™ MRI Head Coil, Mirror Holder

Basic Information

• Brand Name: Encompass™ MRI Head Coil, Mirror Holder
• Primary DI: 04251269207273
• Version / Model: 01
• Catalog Number: 119878
• Company Name: Noras MRI products GmbH
• Labeler DUNS: 312844095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-06
• Public Version: 1
• Public Version Date: 2022-07-14
• Public Version Status: New
• Public Device Record Key: aa3fee5c-c2bc-4983-b76a-06c0d1e6c66b

Device Description

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).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOS	Coil, Magnetic Resonance, Specialty	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40749	MRI system coil, radio-frequency	A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251269207273	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190668	000