Viva-mate 3

GUDID 04560224971600

NAKANISHI INC.

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• Primary Device ID: 04560224971600
• NIH Device Record Key: 123558ab-23dd-44f5-a878-e204b348b2ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viva-mate 3
• Version Model Number: Viva-mate 3 Motor
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	04560224971600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990646

FDA Product Code

• EKX: Handpiece, direct drive, ac-powered

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: 2020-08-27
• Device Publish Date: 2020-08-19

On-Brand Devices [Viva-mate 3]

• 04560264572638: Viva-mate 3 Charger (120V)
• 04560224971600: Viva-mate 3 Motor