Duns Number:047019725
Catalog Number
643688
Brand Name
Synspar Advance
Version/Model Number
643688
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2018
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
-
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
ca6a8699-589b-4381-b126-c82c0a70b1c2
Public Version Date
November 29, 2018
Public Version Number
4
DI Record Publish Date
December 22, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1344 |