Encompass 15 Channel MRI Head Coil - 3T 119781

GUDID 04251269204470

Head Coil

Noras MRI products GmbH

MRI system coil, radio-frequency
Primary Device ID04251269204470
NIH Device Record Key166321ac-932e-49f6-a2e6-f54614f0698b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncompass 15 Channel MRI Head Coil - 3T
Version Model Number01
Catalog Number119781
Company DUNS312844095
Company NameNoras MRI products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
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
Emailsales@noras.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104251269204470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2019-11-15

Devices Manufactured by Noras MRI products GmbH

04251269207297 - iLoop Interventional Coil 0.55T 2024-06-19 The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination
04251269207341 - Breast BI 7 MR Coil Set 1.5T2023-09-18 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 3T2023-09-18 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
04251269207334 - Breast BI 7 MR Coil Set 1.5T2023-07-24 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
04251269207327 - Breast BI 7 MR Coil Set 3T2023-05-30 The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breas
04251269207303 - OR Head Holder LUCY with HeadCoilSet Philips 1.5T2023-05-19 The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scann
04251269207310 - OR Head Holder LUCY with HeadCoilSet Philips 3T2023-05-19 The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scann
04251269203022 - Uni-Lift – Base Unit2022-07-14 The Uni-Lift is used for aiding MR guided prostate interventions such as prostate biopsy or therapy.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.