NORAS OR HEADCOIL Top Array Philips 3T Refurbished 117815

GUDID 04251269206184

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

MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency
Primary Device ID04251269206184
NIH Device Record Keye6b126c6-5710-4884-bd59-6f611f3aef5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNORAS OR HEADCOIL Top Array Philips 3T Refurbished
Version Model Number05
Catalog Number117815
Company DUNS312844095
Company NameNoras MRI products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49931299270
Emailinfo@noras.de
Phone+49931299270
Emailinfo@noras.de
Phone+49931299270
Emailinfo@noras.de
Phone+49931299270
Emailinfo@noras.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104251269206184 [Primary]
GS104251269206184 [Primary]
GS104251269206184 [Primary]
GS104251269206184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty
MOSCoil, Magnetic Resonance, Specialty
MOSCoil, Magnetic Resonance, Specialty
MOSCoil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [NORAS OR HEADCOIL Top Array Philips 3T Refurbished]

04251269205101Head Coil for MRI
04251269206184The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner,

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