VA2-HP

GUDID 04560264518674

NAKANISHI INC.

Ultrasonic dental scaling/debridement system

Primary Device ID	04560264518674
NIH Device Record Key	4e08bf1a-ecb5-412f-a21a-f5dceeb88931
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264518674 [Primary]
GS1	04560264557420 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K113530

FDA Product Code

ELC	Scaler, Ultrasonic