Duns Number:315165357
Device Description: VITAPAN PLUS, D3, R45
Catalog Number
-
Brand Name
VITAPAN Plus
Version/Model Number
AVD3R45
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
K914476
Product Code
ELM
Product Code Name
Denture, plastic, teeth
Public Device Record Key
18fae3c7-266b-4cbc-a9d7-60cc5ccd3171
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 18, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 11685 |