Duns Number:054618202
Device Description: VINTAGE PRO COLOR EFFECT O 50G
Catalog Number
P0426
Brand Name
VINTAGE PRO COLOR EFFECT O 50G
Version/Model Number
P0426
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
-
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
K181496
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
f2ca4d7d-1373-4f7f-a12a-6082c31f8f75
Public Version Date
February 11, 2021
Public Version Number
1
DI Record Publish Date
February 03, 2021
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 | 691 |
2 | A medical device with a moderate to high risk that requires special controls. | 2950 |