FDA.reportPublic FDA data

calmping screw M10 long Set

Primary DI
04251269204357
Brand
calmping screw M10 long Set
Company
Noras MRI products GmbH
Model
01
Catalog number
119680
Device description
The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment. Together with the NORAS OR head coils 1.5T/3T the head holder LUCY is used for intra-operative MR imaging during neurosurgery on the open skull.
Published
2022-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBLHolder, Head, Neurosurgical (Skull Clamp)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211658000OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3TNoras Mri Products GmbH2022-03-03MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251269204357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251269204357042512692043574251269204357

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
+49931299270sales@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

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Primary DI, Brand, Company table
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