Duns Number:880141023
Device Description: Veratone Posterior
Catalog Number
93811
Brand Name
Veratone Posterior
Version/Model Number
93811
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
-
Product Code
ELM
Product Code Name
Denture, Plastic, Teeth
Public Device Record Key
4c18ad8d-25da-4d9d-ad64-d55c35a069d8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 02, 2017
Package DI Number
17701126550232
Quantity per Package
20
Contains DI Package
07701126550235
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 94 |