NeoZoline NZ3123-2

GUDID 09421901970093

Vent Tube Mod Armstrong - Double

ADEPT MEDICAL LIMITED

Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube 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