Viva-mate

GUDID 04560224971617

NAKANISHI INC.

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• Primary Device ID: 04560224971617
• NIH Device Record Key: 2d5890f0-3eac-43e6-ad33-21ccae215494
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viva-mate
• Version Model Number: Viva-mate 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	04560224971617 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-12
• Device Publish Date: 2020-06-12

On-Brand Devices [Viva-mate]

• 04560264540422: VIVA-MATE Motor Cord
• 04560224971617: Viva-mate Motor