Duns Number:005209325
Device Description: Two-Tone Dental Plaque Disclosing Liquid; swab, each
Catalog Number
-
Brand Name
HurriView II
Version/Model Number
base unit
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 03, 2019
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QJC
Product Code Name
Plaque Disclosing Agent
Public Device Record Key
c6f0689e-87d8-4a0b-b1a6-92e5fa3b1175
Public Version Date
January 08, 2020
Public Version Number
4
DI Record Publish Date
October 01, 2019
Package DI Number
02723797110575
Quantity per Package
24
Contains DI Package
01723797110576
Package Discontinue Date
December 03, 2019
Package Status
Not in Commercial Distribution
Package Type
shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |