FDA.reportPublic FDA data

Sonesta

Primary DI
07350006950032
Brand
Sonesta
Company
Sonesta Medical AB
Model
S3
Published
2017-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
MMZTable, Cystometric, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350006950032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350006950032073500069500327350006950032

GMDN Terms#

Term, Definition table
TermDefinition
Urological operating table, electrohydraulicA mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. Commonly known as a transurethral resection (TUR) table, its surface consists of a flat section with a headrest; it includes adjustable leg holders/stirrups either directly attached to the table or to its side rails. It may also include traction handles and an integrated urine/irrigation fluid collection tray with a filter to catch urinary stones and/or stone fragments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
355118308
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350006950063Sonesta P3P3-230V2025-10-14
07350006950148Sonesta F3F3-230V2025-10-14
07350006950049Sonesta F3F3-120V2025-09-30
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
07350006950018Sonesta62102017-03-28
07350006950025SonestaS22017-03-28
00735000695003SonestaS32017-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841736125271SkytronSKYTRON LLCMMZ2026-05-01
07350006950063Sonesta P3Sonesta Medical ABMMZ2025-10-14
07350006950070Sonesta P3Sonesta Medical ABMMZ2025-09-30
07350006950087Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950094Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950117Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950124Sonesta P3Sonesta Medical ABMMZ2025-09-30
00850977007959IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMZ2025-08-07
00618125192267SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00618125192274SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192264SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192271SterisTIDI PRODUCTS, LLCMMZ2025-07-01
08594211570411TRYTABLEMEDKONSULT medical technology s.r.o.MMZ2024-09-23
00817463026429Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026436Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026306Oakworks MedicalOAKWORKS, INC.MMZ2023-07-17
00817463026245Oakworks MedicalOAKWORKS, INC.MMZ2023-07-10
00817463026269Oakworks MedicalOAKWORKS, INC.MMZ2023-07-10
00817463026030Oakworks MedicalOAKWORKS, INC.MMZ2023-06-29
00618125139989TIDITIDI PRODUCTS, LLCMMZ2022-09-29
00618125140008TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
00618125157679Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
00618125157686Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125139986TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125140005TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125140081TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157447DASSETIDI PRODUCTS, LLCMMZ2022-09-29
10618125157676Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157683Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157966Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29