FDA.reportPublic FDA data

trophon3

Primary DI
09350855000740
Brand
trophon3
Company
NANOSONICS LIMITED
Model
N05035-US
Device description
Contents: 1 x N05035-1 trophon3 10 x N05006 trophon AcuTrace Operator Card 10 X N05007 trophon AcuTrace Medical Instrument Tag
Published
2025-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350855000740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855000740093508550007409350855000740

GMDN Terms#

Term, Definition table
TermDefinition
Atomized-chemical device disinfectorAn electrically-powered unit designed for the disinfection of devices at the point-of-use using ultrasonically generated ultra-fine particle aerosolized disinfectant. It consists of a cabinet (e.g., with internal shelves) intended to accept pre-cleaned medical devices/equipment (including electrical devices), an ultrasonic disinfectant atomizer and a control panel. It is intended to be used as an alternative to wipe down disinfection, and is not intended for use in a reprocessing suite.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00-20 °C to +60 °C / -4 °F to +140 °F

Contacts#

Phone, Email table
PhoneEmail
1-844-876-7466customerservice@nanosonics.us

Regulatory Flags#

DUNS number
741021943
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350855000009Trophon EPRN00010-US2016-09-21
09350855000016Trophon EPRN00010-NNA2016-09-21
09350855000023Sonex-HLN000372016-09-21
09350855000030Sonex-HLN00037-NNA2016-09-21
09350855000122Trophon EPRN00010-US-RFB2016-09-21
09350855000559trophon Curved Probe PositionerN00099N000992022-07-08
09350855001037trophon2 RefurbishedN05000-1R2025-11-01
09350855000542trophon Chemical IndicatorN05003N050032022-05-12
09350855000047Trophon Chemical IndicatorN000912016-09-21
09350855000054Trophon Chemical IndicatorN00091-NNA2016-09-21
09350855000184trophon2N05000-12018-06-15
09350855000177trophon Chemical IndicatorN050032018-06-15
09350855000849CORIS Smart Drain Adaptor OAN055212026-05-20
09350855000580CORIS QUANTUM Cleaning AgentN055032026-05-20
09350855000818CORIS Device EngineN055162026-05-20
09350855000832CORIS Adaptor O1N055172026-05-20
09350855000856CORIS Smart DrainN055202026-05-20
09350855000863CORIS Maintenance KitN055222026-05-20
09350855000887CORIS Flushing AccessoryN055282026-05-20
09350855000894CORIS Smart Seal AN055232026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09350855001037trophon2 RefurbishedNANOSONICS LIMITEDOUJ2025-11-01
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
09350855000184trophon2NANOSONICS 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