Sonex-HL

GUDID 09350855000078

Sonex-HL Each Unit AHECC 2847.00.00 (GE VARIANT)

NANOSONICS LIMITED

Medical device disinfectant 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: 09350855000078
• NIH Device Record Key: 990c6969-6ba0-4e5a-a4ce-37d53009f911
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonex-HL
• Version Model Number: N00037
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	09350855000023 [Primary]
GS1	09350855000061 [Package]; Contains: 09350855000023; Package: inner shipper [6 Units]; In Commercial Distribution
GS1	09350855000078 [Package]; Contains: 09350855000061; Package: Outer shipper [2 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: 2019-05-03
• Device Publish Date: 2016-09-21

On-Brand Devices [Sonex-HL]

• 09350855000078: Sonex-HL Each Unit AHECC 2847.00.00 (GE VARIANT)
• 09350855000092: Sonex-HL Each unit AHECC 2847.00.00 (NNA VARIANT)