VA2-HP

GUDID 04560264556522

NAKANISHI INC.

Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece Ultrasonic dental scaling/debridement system handpiece

• Primary Device ID: 04560264556522
• NIH Device Record Key: f5ed8c0e-8afb-4367-855d-bc344e53fc15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VA2-HP
• Version Model Number: VA2-HP
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264556522 [Primary]
GS1	04560264557420 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113530

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

[04560264556522]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-23
• Device Publish Date: 2018-03-19

On-Brand Devices [VA2-HP]

• 04560264556522: VA2-HP
• 04560264518674: VA2-HP