Duns Number:006385173
Device Description: Whip Mix VeriGuide™ OS is a 3D printed resin for producing drilling guides used in dentals Whip Mix VeriGuide™ OS is a 3D printed resin for producing drilling guides used in dentalsurgery.
Catalog Number
71175
Brand Name
Veriguide OS
Version/Model Number
71175
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
9f196c89-7913-4e2a-9c9a-e5cdf1b5139f
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
September 22, 2020
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 | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 293 |
U | Unclassified | 1 |