FDA.reportPublic FDA data

Handle Bar

Primary DI
04251269203268
Brand
Handle Bar
Company
Noras MRI products GmbH
Model
01
Catalog number
118391
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
04251269203268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251269203268042512692032684251269203268

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
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
07630894822469APTUSMedartis AGGDF2026-11-02
07630894822476APTUSMedartis AGGDF2026-11-02
07630894822483APTUSMedartis AGGDF2026-11-02
G383S10931921603SURJEXSURJEXGDF2026-10-31
00850084501012Xpansion® Micro-Autografting KitNEW HORIZON HEALTHCARE MANAGEMENT LLCGDF2026-07-28
06976712970334Hemo NeedleMicro-Energy Medical Technology Co., LtdGDF2026-07-13
04048223069738TunnEler 235Pajunk GmbH MedizintechnologieGDF2026-06-10
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
08056138586338MarkXM.D.L. S.R.L.GDF2025-02-28
08057276004715MarkXM.D.L. S.R.L.GDF2025-02-28
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
10840199505767Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505774Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505798Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505804Needle HolderKOROS U.S.A., INC.GDF2022-04-01