Duns Number:315666321
Device Description: Porcelain Powder for clinical use.
Catalog Number
66003467
Brand Name
HeraCeram Opalschneide OS4, 100g
Version/Model Number
66003467
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K002993
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
7dc16c1c-aca7-48b0-b7d1-3a9f841879f5
Public Version Date
July 24, 2018
Public Version Number
4
DI Record Publish Date
September 15, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5609 |