FDA.reportPublic FDA data

Sonesta F3

Primary DI
07350006950049
Brand
Sonesta F3
Company
Sonesta Medical AB
Model
F3-120V
Device description
The F3 is a unique procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures, with carbon-fiber support for use with a C-arm. The table has been developed to ensure optimal patient comfort, while focusing on facilitating the positioning of the patient safely and precisely during video fluoroscopy or urology examinations and procedures.
Published
2025-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IXRTable, Radiographic, Tilting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350006950049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350006950049073500069500497350006950049

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Regulatory Flags#

DUNS number
355118308
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350006950063Sonesta P3P3-230V2025-10-14
07350006950148Sonesta F3F3-230V2025-10-14
07350006950070Sonesta P3P3-120V2025-09-30
07350006950087Sonesta P2P2-120V2025-09-30
07350006950094Sonesta P2P2-230V2025-09-30
07350006950117Sonesta P2P2-100V2025-09-30
07350006950124Sonesta P3P3-100V2025-09-30
07350006950056SonestaSST2019-06-14
07350006950032SonestaS32017-03-28
07350006950018Sonesta62102017-03-28
07350006950025SonestaS22017-03-28
00735000695003SonestaS32017-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350006950148Sonesta F3Sonesta Medical ABIXR2025-10-14
00198953043301NAGE Hualun Medical Systems Co., LtdIXR2025-04-22
00850061871015IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871022IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871008IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00850977007997IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00817463026405Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026412Oakworks Medical OAKWORKS, INC.IXR2023-12-06
00817463026429Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026436Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026184Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026214Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026221Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026238Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026252Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026276Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026306Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026313Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026320Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463025941Oakworks MedicalOAKWORKS, INC.IXR2023-07-11
00817463025972Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463025989Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026054Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026061Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026092Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026177Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026245Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026269Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026283Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026290Oakworks MedicalOAKWORKS, INC.IXR2023-07-10