Duns Number:005473608
Device Description: MI Paste™ 10-pack, 10 tubes (40g each) Strawberry only
Catalog Number
424505
Brand Name
MI Paste™
Version/Model Number
424505
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042200,K042200
Product Code
EJR
Product Code Name
AGENT, POLISHING, ABRASIVE, ORAL CAVITY
Public Device Record Key
6c916345-08f9-4b01-87c7-c1f8b5ab7b4a
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
February 10, 2017
Package DI Number
D6584245052
Quantity per Package
30
Contains DI Package
D6584245051
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |