Duns Number:009900424
Device Description: Absolute Polishers™; Cup Shapers (non-diamond)
Catalog Number
S081
Brand Name
Absolute Polishers™
Version/Model Number
S081
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 10, 2020
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
-
Product Code
EHJ
Product Code Name
Disk, Abrasive
Public Device Record Key
c3d14c65-7eb5-4bd8-9c75-3a1e26d288b3
Public Version Date
April 25, 2022
Public Version Number
3
DI Record Publish Date
August 02, 2019
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |