Sonex-HL

GUDID 09350855000078

Sonex-HL Each Unit AHECC 2847.00.00 (GE VARIANT)

NANOSONICS LIMITED

Medical device disinfectant

• 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)