FDA.reportPublic FDA data

All-Purpose Arch

Primary DI
04251269205668
Brand
All-Purpose Arch
Company
Noras MRI products GmbH
Model
02
Catalog number
113393
Published
2019-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBLHolder, Head, Neurosurgical (Skull Clamp)
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071179000
K133506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071179000NORAS OR HEAD HOLDERSiemens Medical Solutions USA, Inc.2007-06-13MOS
K133506000NORAS OR HEAD HOLDER FLEXIBILITYNoras Mri Products GmbH2014-08-06MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251269205668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251269205668042512692056684251269205668

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+499312992714sales@noras.de

Regulatory Flags#

DUNS number
312844095
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251269207389Breast BI 7 MR Coil Set 3T101188902025-04-09
04251269207402iLoop Interventional Coil 0.55T 021210482025-04-09
04251269207365Breast BI 7 MR Coil Set 1.5T071189842025-03-11
04251269207372Breast BI 7 MR Coil 1.5T041188792025-03-11
04251269207297iLoop Interventional Coil 0.55T 011210482024-06-11
04251269207341Breast BI 7 MR Coil Set 1.5T061189842023-09-08
04251269207358Breast BI 7 MR Coil Set 3T091188902023-09-08
04251269207334Breast BI 7 MR Coil Set 1.5T051189842023-07-14
04251269207327Breast BI 7 MR Coil Set 3T081188902023-05-22
04251269207303OR Head Holder LUCY with HeadCoilSet Philips 1.5T021202812023-05-11
04251269207310OR Head Holder LUCY with HeadCoilSet Philips 3T021202822023-05-11
04251269203022Uni-Lift – Base Unit011183282022-07-06
04251269203039Table Docking Uni-Lift for Siemens Aera/Skyra011183312022-07-06
04251269203046Positioning Aid - UniLift011183332022-07-06
04251269203053Table Docking Uni-Lift for GE - 450W/750W011190822022-07-06
04251269203060Table Docking Uni-Lift for Siemens Espree011186672022-07-06
04251269203213Uni-Lift Prostate Intervention Device011183302022-07-06
04251269203220biospie- sledge011138832022-07-06
04251269203237Grid for Uni-Lift011186242022-07-06
04251269203244Equipment holder011186752022-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
04260486610483NHAC 1.5T PH I 16LMT Medical Systems GmbHMOS2024-04-23
04260486610537NHAC 3.0T PH I 16LMT Medical Systems GmbHMOS2024-04-23
04260486610582NBAC 1.5T PH I SpineLMT Medical Systems GmbHMOS2024-04-23
04260486610599NBAC 3.0T PH I SpineLMT Medical Systems GmbHMOS2024-04-23
08056304455055S-scan OpenESAOTE SPAMOS2023-12-14
04260486610940NBAC 1.5T SMS, FlexLMT Medical Systems GmbHMOS2023-06-01
04260486610957NBAC 1.5T PH I FlexLMT Medical Systems GmbHMOS2023-06-01
04260486610377NBAC 3.0T GE H, FlexLMT Medical Systems GmbHMOS2022-02-14
04260486610544NHAC 3.0T GE P 16LMT Medical Systems GmbHMOS2022-02-14
04260486610612NBAC 3.0T GE P, SpineLMT Medical Systems GmbHMOS2022-02-14
04260486610636NBAC 3.0T SMS, SpineLMT Medical Systems GmbHMOS2021-12-08
04260486610469NHAC 1.5T GE P 16LMT Medical Systems GmbHMOS2021-10-27
04260486610513NHAC 3.0T GE P 16LMT Medical Systems GmbHMOS2021-10-27
04260486610230NBAC 1.5T SMS, FlexLMT Medical Systems GmbHMOS2020-08-23
04260486610438NHAC 1.5T SMS 16LMT Medical Systems GmbHMOS2020-08-23
04260486610629NBAC 1.5T SMS, SpineLMT Medical Systems GmbHMOS2020-08-23
04260486610445NHAC 3.0T SMS 16LMT Medical Systems GmbHMOS2018-03-15
04260486610209NBAC 3.0T SMS, SpineLMT Medical Systems GmbHMOS2018-03-14
04260486610216NBAC 3.0T SMS, FlexLMT Medical Systems GmbHMOS2018-03-14
08056304450029G-scan BrioESAOTE SPAMOS2016-09-27
08056304451095S-scanESAOTE SPAMOS2016-09-27
08165890202018AtamA™ SystemMONTERIS MEDICAL INCMOS2016-09-02
049876701013594ch Flex SPEEDERCANON INC.MOS2016-09-01
10381780253716MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256113MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256120MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256137MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256144MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02