Duns Number:436661136
Device Description: Ena ShinyShiny 14 RA 6 pcsWhite Coarse Diamond Rubber Points, Composite polishingSpeed 800 Ena ShinyShiny 14 RA 6 pcsWhite Coarse Diamond Rubber Points, Composite polishingSpeed 8000-15000 rpm
Catalog Number
CS014
Brand Name
Ena Shiny
Version/Model Number
CS014
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
EHL
Product Code Name
Point, Abrasive
Public Device Record Key
3973ff77-88e9-488d-a6e9-3b0bc27da4fc
Public Version Date
December 15, 2021
Public Version Number
1
DI Record Publish Date
December 07, 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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 231 |