Duns Number:005473608
Device Description: UNIFAST™ Trad Ivory, 100g powder
Catalog Number
339104
Brand Name
UNIFAST™
Version/Model Number
339104
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
-
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
K984365,K984365
Product Code
EBG
Product Code Name
CROWN AND BRIDGE, TEMPORARY, RESIN
Public Device Record Key
7794e315-ca5e-4c9b-8897-1448f6dfc970
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
Package DI Number
20386040000960
Quantity per Package
10
Contains DI Package
10386040000963
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
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 |