FDA.reportPublic FDA data

Positioning Aid - UniLift

Primary DI
04251269203046
Brand
Positioning Aid - UniLift
Company
Noras MRI products GmbH
Model
01
Catalog number
118333
Device description
The Uni-Lift is used for aiding MR guided prostate interventions such as prostate biopsy or therapy.
Published
2022-07-06
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
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251269203046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251269203046042512692030464251269203046

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
Premarket exempt
true
Lot or batch
true
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
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
04251269203251Leg rest - adjustable011183942022-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344044795MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
10197344044801MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
07630037864165APTUSMedartis AGGDF2024-03-22
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
08033860028596BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
10840199534132Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534149Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534156Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534163Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534170Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534187Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534194Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534200Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534217Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534224Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534231Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534248Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534255Needle HolderKOROS U.S.A., INC.GDF2022-08-01