UF(II) Fixture UF(II) 4007S

GUDID 08806195983584

DIO Corporation

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• Primary Device ID: 08806195983584
• NIH Device Record Key: 7594c773-2c53-4950-b9c2-02bb56fc5957
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UF(II) Fixture
• Version Model Number: UF(II) 4007S
• Catalog Number: UF(II) 4007S
• Company DUNS: 631085206
• Company Name: DIO Corporation
• Device Count: 1
• DM Exempt: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806195983584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170608

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-07
• Device Publish Date: 2022-03-30

On-Brand Devices [UF(II) Fixture]

• 08806195983799: UF(II) 6505UV3
• 08806195983782: UF(II) 6005UV3
• 08806195983775: UF(II) 5505UV3
• 08806195983768: UF(II) 5005UV3
• 08806195983751: UF(II) 4505UV3
• 08806195983744: UF(II) 4007UV3
• 08806195983737: UF(II) 4005UV3
• 08806195983720: UF(II) 7005SF
• 08806195983713: UF(II) 6505SF
• 08806195983706: UF(II) 6005SF
• 08806195983690: UF(II) 5505SF
• 08806195983683: UF(II) 5005SF
• 08806195983676: UF(II) 4505SF
• 08806195983669: UF(II) 4007SF
• 08806195983652: UF(II) 4005SF
• 08806195983645: UF(II) 7005S
• 08806195983638: UF(II) 6505S
• 08806195983621: UF(II) 6005S
• 08806195983614: UF(II) 5505S
• 08806195983607: UF(II) 5005S
• 08806195983591: UF(II) 4505S
• 08806195983584: UF(II) 4007S
• 08806195983577: UF(II) 4005S