FDA.reportPublic FDA data

trophon2

Primary DI
09350855000184
Brand
trophon2
Company
NANOSONICS LIMITED
Model
N05000-1
Device description
High Level Disinfection System
Published
2018-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, MistRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173865000trophon2Nanosonics Limited2018-04-24OUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350855000191PackageGS11In Commercial Distribution
09350855000184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855000191093508550001919350855000191
09350855000184093508550001849350855000184

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on a medical device (e.g., surgical or dental instrument) and/or facility surface; it may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
741021943
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350855000580CORIS QUANTUM Cleaning AgentN055032026-05-20
09350855000818CORIS Device EngineN055162026-05-20
09350855000832CORIS Adaptor O1N055172026-05-20
09350855000849CORIS Smart Drain Adaptor OAN055212026-05-20
09350855000856CORIS Smart DrainN055202026-05-20
09350855000863CORIS Maintenance KitN055222026-05-20
09350855000887CORIS Flushing AccessoryN055282026-05-20
09350855000894CORIS Smart Seal AN055232026-05-20
09350855000900CORIS Smart Seal BN055242026-05-20
09350855000993CORIS Device BodyN055152026-05-20
09350855001037trophon2 RefurbishedN05000-1R2025-11-01
09350855000740trophon3N05035-US2025-08-14
09350855000146trophon Sonex-HLN05002N05002-12PK2018-06-15
09350855000542trophon Chemical IndicatorN05003N050032022-05-12
09350855000047Trophon Chemical IndicatorN000912016-09-21
09350855000054Trophon Chemical IndicatorN00091-NNA2016-09-21
09350855000177trophon Chemical IndicatorN050032018-06-15
09350855000573trophon Wireless Ultrasound Probe HolderN05030-USN05030-US2024-10-25
09350855000009Trophon EPRN00010-US2016-09-21
09350855000016Trophon EPRN00010-NNA2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09350855001037trophon2 RefurbishedNANOSONICS LIMITEDOUJ2025-11-01
09350855000740trophon3NANOSONICS LIMITEDOUJ2025-08-14
09350855000573trophon Wireless Ultrasound Probe HolderNANOSONICS LIMITEDOUJ2024-10-25
09350855000559trophon Curved Probe PositionerNANOSONICS LIMITEDOUJ2022-07-08
09350855000566trophon Curved Probe PositionerNANOSONICS LIMITEDOUJ2022-07-08
09350855000146trophon Sonex-HLNANOSONICS LIMITEDOUJ2018-06-15
09350855000160trophon Sonex-HLNANOSONICS LIMITEDOUJ2018-06-15
09350855000009Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000016Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000023Sonex-HLNANOSONICS LIMITEDOUJ2016-09-21
09350855000030Sonex-HLNANOSONICS LIMITEDOUJ2016-09-21
09350855000122Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000108Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000115Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000092Sonex-HLNANOSONICS LIMITEDOUJ2016-09-21
09350855000139Trophon EPRNANOSONICS LIMITEDOUJ2016-09-21
09350855000078Sonex-HLNANOSONICS LIMITEDOUJ2016-09-21