Duns Number:695735177
Device Description: Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ra 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.
Catalog Number
-
Brand Name
Portable Dental X-ray (NR-F350 with Back scatter shield)
Version/Model Number
NP-350E
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201800,K201800,K201800
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
1478d713-3cf0-4e98-a0e2-4818da34689a
Public Version Date
February 26, 2021
Public Version Number
1
DI Record Publish Date
February 18, 2021
Package DI Number
08800072313426
Quantity per Package
1
Contains DI Package
08800072313419
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box