NORAS OR HEADCOIL Top Array Siemens 3T Refurbished 117816

GUDID 04251269206207

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 ID04251269206207
NIH Device Record Key96207bcb-7e9f-4cb2-a683-8f597004584b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNORAS OR HEADCOIL Top Array Siemens 3T Refurbished
Version Model Number04
Catalog Number117816
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
GS104251269206207 [Primary]
GS104251269206207 [Primary]
GS104251269206207 [Primary]
GS104251269206207 [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 Siemens 3T Refurbished]

0425126920038003
04251269206207The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner,

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