Duns Number:857278431
Device Description: Variety pack (30 Single Shots) All three brands in one (Visiclear x2, Duracetal A1x1,A2x1, Variety pack (30 Single Shots) All three brands in one (Visiclear x2, Duracetal A1x1,A2x1,A3x1,A3.5x1,A4x1,B1x1,B2x1,B3x1,B4x1,C1x1,C2x1,C3x1,C4x1,D2x1,D3x1,D4x1,G1x1,G2x1,G3x1,P1x1,P2x1,P3x1, Duraflex DPx2,MPx2,Px2)
Catalog Number
-
Brand Name
Hot Shot Elite Single Shot Assortment
Version/Model Number
VP-0100
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
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
3b032cbe-8ec0-408c-aa22-457537cd0078
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
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 | 134 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7702 |