Duns Number:009900424
Device Description: Absolute Polishers™; Cup Smoothers (non-diamond)
Catalog Number
S083
Brand Name
Absolute Polishers™
Version/Model Number
S083
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 14, 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
5352fa01-7b59-4a56-94be-853d9e5fbcce
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 |