Duns Number:137217043
Device Description: ABSORBENT POINTS (180/box) Type: Cell Pack, Size: 100; For more information: https://www.s ABSORBENT POINTS (180/box) Type: Cell Pack, Size: 100; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
Catalog Number
103-9128
Brand Name
SCOTT'S ABSORBENT POINTS CELL PACK 180/bx CC # 100
Version/Model Number
103-9128
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
Yes
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
EKN
Product Code Name
POINT, PAPER, ENDODONTIC
Public Device Record Key
53192b6a-ee8d-461d-95b2-cd5d6672e884
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 27, 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 | 1050 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |