Duns Number:137217043
Device Description: HP MIXING TIPS (48/bag) Color: Purple, Size: Extra Large, 7.5mm; For more information: htt HP MIXING TIPS (48/bag) Color: Purple, Size: Extra Large, 7.5mm; For more information: https://www.scottsdental.com/catalog/product/view/id/23794/s/hp-mixing-tips-scott-s-select/
Catalog Number
104-8107
Brand Name
SCOTT'S HP MIX TIPS X-LARGE 7.5mm PURPLE 48/BAG
Version/Model Number
104-8107
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
EID
Product Code Name
SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
Public Device Record Key
a5266f54-76bd-4337-b9aa-64d8b4b91d5f
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 |