Duns Number:863358955
Device Description: Intraskan DC Plus with 33" Support tube is High Frequency Extra oral X-Ray source to be us Intraskan DC Plus with 33" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose.
Catalog Number
-
Brand Name
Intraskan DC Plus
Version/Model Number
303-000134-26
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
K170967
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
25268aa9-9fac-42b4-8fb7-40728a3ee2f2
Public Version Date
January 19, 2022
Public Version Number
2
DI Record Publish Date
August 10, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |