Duns Number:307549241
Device Description: Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges
Catalog Number
-
Brand Name
ASPIJECT
Version/Model Number
2055
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K002168
Product Code
EJI
Product Code Name
Syringe, Cartridge
Public Device Record Key
90dcc8e2-a6e6-44de-b3c9-eacab96346d3
Public Version Date
November 22, 2018
Public Version Number
4
DI Record Publish Date
August 25, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |