Duns Number:201637158
Catalog Number
-
Brand Name
PeriAcryl
Version/Model Number
P-ACRYLU(C)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 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
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
K071484,K071484
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
8e8c96c2-420e-43bc-baa5-ac337055ba60
Public Version Date
March 01, 2019
Public Version Number
5
DI Record Publish Date
February 13, 2017
Package DI Number
D7950000041
Quantity per Package
12
Contains DI Package
D7950000030
Package Discontinue Date
March 01, 2019
Package Status
Not in Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |