Duns Number:689229516
Device Description: Dental Extraoral Source X-ray System (Horizontal Arm Length 900mm)
Catalog Number
-
Brand Name
EzRay Air W
Version/Model Number
VEX-S300W
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
K163705
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
5f6d488a-c46b-4f0c-a062-aae149c03fca
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 30, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 76 |