FDA.reportPublic FDA data

Sonex-HL

Primary DI
09350855000078
Brand
Sonex-HL
Company
NANOSONICS LIMITED
Model
N00037
Device description
Sonex-HL Each Unit AHECC 2847.00.00 (GE VARIANT)
Published
2016-09-21
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
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103059000TROPHONNanosonics Limited2011-02-24OUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350855000061PackageGS16In Commercial Distribution
09350855000078PackageGS12In Commercial Distribution
09350855000023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855000061093508550000619350855000061
09350855000078093508550000789350855000078
09350855000023093508550000239350855000023

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfectantA substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological 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 of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe.

Sterilization Methods#

Method table
Method

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
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