Duns Number:486026102
Device Description: The non-sterile cartridge holder is used to connect the device to the cartridge. In order The non-sterile cartridge holder is used to connect the device to the cartridge. In order to ensure the quantity scale reading on the prefilled cartridge, the cartridge holder is transparent.
Catalog Number
DP05
Brand Name
Dentapen Cartridge holder
Version/Model Number
Cartridge hodler for Dentapen
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJI
Product Code Name
Syringe, Cartridge
Public Device Record Key
029a8cc0-a303-451f-8722-0e4e7ca8be1b
Public Version Date
November 22, 2018
Public Version Number
1
DI Record Publish Date
October 22, 2018
Package DI Number
EJUVDP058
Quantity per Package
5
Contains DI Package
EJUVDP057
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Caron box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |