NeoZoline NZ3123-2

GUDID 09421901970093

Vent Tube Mod Armstrong - Double

ADEPT MEDICAL LIMITED

Tympanostomy tube

• Primary Device ID: 09421901970093
• NIH Device Record Key: 4926bf40-02c7-46fe-a7a1-e11c9e719738
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoZoline
• Version Model Number: NZ3123-2
• Catalog Number: NZ3123-2
• Company DUNS: 592534619
• Company Name: ADEPT MEDICAL LIMITED
• Device Count: 10
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421901970093 [Primary]
GS1	09421902825538 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061058

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-22
• Device Publish Date: 2016-01-13

On-Brand Devices [NeoZoline]

• 09421901970154: Vent Tube Straight Tube - Double
• 09421901970147: Vent Tube Straight Tube
• 09421901970130: Vent Tube Bevel Bobbin - Double
• 09421901970123: Vent Tube Bevel Bobbin
• 09421901970116: Vent Tube Mod Armstrong Tail - Double
• 09421901970109: Vent Tube Mod Armstrong - Tail
• 09421901970093: Vent Tube Mod Armstrong - Double
• 09421901970086: Vent Tube Mod Armstrong
• 09421901970079: Vent Tube Armstrong Tail - Double
• 09421901970062: Vent Tube Armstrong Tail
• 09421901970048: Vent Tube Armstrong
• 09421901970031: Vent Tube Collar Button Tail - Double
• 09421901970024: Vent Tube Collar Button Tail
• 09421901970017: Vent Tube Collar Button Double
• 09421901970000: Vent Tube Collar Button
• 09421901970451: Jobson Horne Probe