Duns Number:514320345
Device Description: Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient posit Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items
Catalog Number
-
Brand Name
PantOs 16 xp Ceph
Version/Model Number
8468200500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K031801
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
bbfd0b73-d0fb-4d41-9c48-9809889047ee
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 10, 2016
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. | 16 |