Duns Number:564251911
Device Description: Colour touch screen Dell 24 Touch monitor- P2418HT - 60.5 cm (23.8) Black ITL for Zirkonza Colour touch screen Dell 24 Touch monitor- P2418HT - 60.5 cm (23.8) Black ITL for Zirkonzahn scanner
Catalog Number
-
Brand Name
Colour touch screen Dell 24 Touch monitor- P2418HT - 60.5 cm (23.8) Black ITL
Version/Model Number
KT004118
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
-
Product Code
NOF
Product Code Name
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Public Device Record Key
f06d9e78-cf2b-425b-8ca9-3e35d23c4ef3
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
June 23, 2021
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 | 1369 |
2 | A medical device with a moderate to high risk that requires special controls. | 4845 |
U | Unclassified | 3 |