Duns Number:124763728
Device Description: A ceramic metal with 97.3 % gold and platinum content.
Catalog Number
-
Brand Name
Bio C Yellow Ceramic Alloy
Version/Model Number
1068001
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
K962326
Product Code
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
3b23a1a0-84a1-41c3-8d49-a40cba454883
Public Version Date
July 09, 2020
Public Version Number
5
DI Record Publish Date
February 16, 2017
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |