Duns Number:119620784
Device Description: Unit, X-ray, Extraoral with timer-PC-1000/Laser 1000
Catalog Number
-
Brand Name
Panoramic Corporation
Version/Model Number
PC-1000/Laser 1000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 24, 2017
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K882436
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
355d6f84-89d5-4357-910c-7b88776c4915
Public Version Date
September 27, 2022
Public Version Number
5
DI Record Publish Date
May 24, 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. | 9 |