Infinix Universal Bond - Primer

GUDID 17290017528370

Universal Bond- Primer 2.5ml for starter kit

NOBIO LTD

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• Primary Device ID: 17290017528370
• NIH Device Record Key: 60dd7581-c523-46aa-aee8-983e9f6b89cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinix Universal Bond - Primer
• Version Model Number: INF-PR-PP-MD2.5ML
• Company DUNS: 532282466
• Company Name: NOBIO LTD
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017528335 [Primary]
GS1	17290017528370 [Package]; Contains: 07290017528335; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183391

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-26
• Device Publish Date: 2021-03-18

On-Brand Devices [Infinix Universal Bond - Primer]

• 07290017528342: Universal Bond- Primer 5ml for re-fill kit
• 17290017528370: Universal Bond- Primer 2.5ml for starter kit