trophon2

GUDID 09350855000184

High Level Disinfection System

NANOSONICS LIMITED

Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent Medical device disinfection agent

• Primary Device ID: 09350855000184
• NIH Device Record Key: 4c659ccd-360d-4b2b-9393-c06aae45d593
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: trophon2
• Version Model Number: N05000-1
• Company DUNS: 741021943
• Company Name: NANOSONICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	09350855000184 [Primary]
GS1	09350855000191 [Package]; Package: Outershipper [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173865

FDA Product Code

• OUJ: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-09-09
• Device Publish Date: 2018-06-15

Devices Manufactured by NANOSONICS LIMITED

• 09350855000566 - trophon Curved Probe Positioner: 2022-07-18 Curved Probe Positioner
• 09350855000542 - trophon Chemical Indicator: 2022-05-20 Chemical Indicator
• 09350855000047 - Trophon Chemical Indicator: 2021-02-19 Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT)
• 09350855000054 - Trophon Chemical Indicator: 2021-02-19 Chemical Indicator US SP-P18 (NNA VARIANT)
• 09350855000108 - Trophon EPR: 2020-09-09 Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)
• 09350855000115 - Trophon EPR: 2020-09-09 Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT)
• 09350855000092 - Sonex-HL: 2020-09-09 Sonex-HL Each unit AHECC 2847.00.00 (NNA VARIANT)
• 09350855000139 - Trophon EPR: 2020-09-09 Trophon US Refurbished