Trophon EPR

GUDID 09350855000108

Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)

NANOSONICS LIMITED

Medical device disinfection agent

• Primary Device ID: 09350855000108
• NIH Device Record Key: f43cd76d-2012-4b2b-9b9b-6240056e9531
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trophon EPR
• Version Model Number: N00010-US
• 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	09350855000009 [Primary]
GS1	09350855000108 [Package]; Contains: 09350855000009; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103059

FDA Product Code

• OUJ: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2016-09-21

On-Brand Devices [Trophon EPR]

• 09350855000139: Trophon US Refurbished
• 09350855000115: Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT)
• 09350855000108: Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)