Duns Number:324001916
Device Description: CREATION Wax 6x8g yellow
Catalog Number
-
Brand Name
NA
Version/Model Number
760-0014
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGD
Product Code Name
WAX, DENTAL, INTRAORAL
Public Device Record Key
423bb8d1-f0ae-41d0-96d5-8a519de5a669
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 22, 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 | 46 |
2 | A medical device with a moderate to high risk that requires special controls. | 21 |