Duns Number:009900424
Device Description: Mixing Tip with Blue Base for 50ml SmarTemp® (Pkg. of 30 pcs.)
Catalog Number
S344
Brand Name
SmarTemp®
Version/Model Number
S344
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K991270,K991270
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
7e825ac3-e2e3-43f4-85f6-b9c6daa714d6
Public Version Date
June 03, 2022
Public Version Number
2
DI Record Publish Date
October 19, 2018
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 |