Portable Dental X-ray (NR-F350 with Back scatter shield)

GUDID 08800072313426

Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is an X-ray device with a DC generator. The handheld device features a main unit (tube head), charger(cradle), and charger AC/DC power supply. The power is supplied by a rechargeable supercapacitor built into a device. This facilitates the portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.

NANORAY CO.,LTD

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 08800072313426
• NIH Device Record Key: 1478d713-3cf0-4e98-a0e2-4818da34689a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Dental X-ray (NR-F350 with Back scatter shield)
• Version Model Number: NP-350E
• Company DUNS: 695735177
• Company Name: NANORAY CO.,LTD
• 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: true
• 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

Customer Support Contacts

• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com
• Phone: +82539624900
• Email: service@nano-ray.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 KiloPascal and 1060 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800072313419 [Primary]
GS1	08800072313426 [Package]; Contains: 08800072313419; Package: Inner Box [1 Units]; In Commercial Distribution
GS1	18800072313430 [Package]; Package: Outer Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201800

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2021-02-26
• Device Publish Date: 2021-02-18

Devices Manufactured by NANORAY CO.,LTD

• 08800072313112 - Portable Dental X-ray (NR-F350 without Back scatter shield): 2021-02-26 Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operati
• 08800072313228 - Portable Dental X-ray (CS 2400P): 2021-02-26 Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operati
• 08800072313327 - Portable Dental X-ray (CS 2300P): 2021-02-26 Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operati
• 08800072313426 - Portable Dental X-ray (NR-F350 with Back scatter shield): 2021-02-26Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is an X-ray device with a DC generator. The handheld device features a main unit (tube head), charger(cradle), and charger AC/DC power supply. The power is supplied by a rechargeable supercapacitor built into a device. This facilitates the portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.
• 08800072313426 - Portable Dental X-ray (NR-F350 with Back scatter shield): 2021-02-26 Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operati
• 08800072313525 - Portable Dental X-ray (R2 Port-X without Back scatter shield): 2021-02-26 Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operati
• 08800072313624 - Portable Dental X-ray (R2 Port-X with Back scatter shield): 2021-02-26 Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operati