NANOSONICS LIMITED

NANOSONICS LIMITED

Address:7-11 Talavera Road,Macquarie Park New South Wales,AU

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers (OUJ) (5) Indicator, Physical/Chemical Sterilization Process (JOJ) (3) High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist (OUJ) (2)

Premarket Exempt

No Yes

Clear

Trophon EPR - 09350855000009 Catalog Number :

Device Description : Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)

Device Class : 2

Duns Number: 741021943

Premarket Exempt : No

Product Code : OUJ

Prescription Use : No

Device Count : 1

Trophon EPR - 09350855000016 Catalog Number :

Device Description : Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT)

Device Class : 2

Duns Number: 741021943

Premarket Exempt : No

Product Code : OUJ

Prescription Use : No

Device Count : 1

Sonex-HL - 09350855000023 Catalog Number :

Device Description : Sonex-HL Each Unit AHECC 2847.00.00 (GE VARIANT)

Device Class :

Duns Number: 741021943

Premarket Exempt : No

Product Code : OUJ

Prescription Use : No

Device Count : 1

Sonex-HL - 09350855000030 Catalog Number :

Device Description : Sonex-HL Each unit AHECC 2847.00.00 (NNA VARIANT)

Device Class : 2

Duns Number: 741021943

Premarket Exempt : No

Product Code : OUJ

Prescription Use : No

Device Count : 1

Trophon Chemical Indicator - 09350855000047 Catalog Number :

Device Description : Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT)

Device Class : 2

Duns Number: 741021943

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Trophon Chemical Indicator - 09350855000054 Catalog Number :

Device Description : Chemical Indicator US SP-P18 (NNA VARIANT)

Device Class : 2

Duns Number: 741021943

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Trophon EPR - 09350855000122 Catalog Number :

Device Description : Trophon US Refurbished

Device Class : 2

Duns Number: 741021943

Premarket Exempt : No

Product Code : OUJ

Prescription Use : No

Device Count : 1

trophon Sonex-HL - 09350855000146 Catalog Number :

Device Description : 35% Hydrogen Peroxide Cartridge

Device Class :

Duns Number: 741021943

Premarket Exempt : No

Product Code : OUJ

Prescription Use : No

Device Count : 1

trophon Chemical Indicator - 09350855000177 Catalog Number :

Device Description : Chemical Indicator

Device Class :

Duns Number: 741021943

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 300

trophon2 - 09350855000184 Catalog Number :

Device Description : High Level Disinfection System

Device Class :

Duns Number: 741021943

Premarket Exempt : No

Product Code : OUJ

Prescription Use : No

Device Count : 1

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