Duns Number:067488114
Device Description: ECS is a hand held and operated crown splitter. A vertical cut is made into the crown by a ECS is a hand held and operated crown splitter. A vertical cut is made into the crown by a cutting wheel and the crown splitter is inserted into the cut. The splitter is squeezed and the unit tip separates and splits the crown open.
Catalog Number
99-1150
Brand Name
TAUB - Trident - ECS (Expandable Crown Splitter)
Version/Model Number
1 mm
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
EIS
Product Code Name
Remover, Crown
Public Device Record Key
e7026eb7-4140-43c7-86fa-9ca32ebb27d2
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
February 25, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |