Duns Number:053707303
Device Description: Calciject prefilled Calcium Hydroxide paste tips, 24
Catalog Number
-
Brand Name
Calciject
Version/Model Number
320003
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
Yes
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
K001050
Product Code
EJK
Product Code Name
Liner, Cavity, Calcium Hydroxide
Public Device Record Key
20119ddf-ec3b-4483-9afa-256b6fbb938b
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
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. | 127 |
U | Unclassified | 10 |