Duns Number:083235549
Device Description: TPH®3 flow Liquid Micro Hybrid Syringe Refill Package, B1, 2 Syringes
Catalog Number
642734
Brand Name
TPH®3 flow Liquid Micro Hybrid
Version/Model Number
642734
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
facadca1-80ee-45b1-9e5d-a5b804359e26
Public Version Date
October 03, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2016
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 | 123 |
2 | A medical device with a moderate to high risk that requires special controls. | 397 |
U | Unclassified | 2 |