Duns Number:688265810
Device Description: The MiniX-V is a hand-held diagnostic dental x-ray system. It is intended to be used by tr The MiniX-V is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.
Catalog Number
DMC-07
Brand Name
MiniX-V
Version/Model Number
1
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
-
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
d8948093-ce05-4878-a65d-d907aaf82b26
Public Version Date
April 01, 2019
Public Version Number
4
DI Record Publish Date
November 07, 2016
Package DI Number
88800021800034
Quantity per Package
8
Contains DI Package
08800021800038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Package