Duns Number:825137818
Device Description: SURFACE DISINFECTANT 1 GAL.
Catalog Number
9430506
Brand Name
Darby Dental Supply, LLC
Version/Model Number
CaviCide
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRJ
Product Code Name
Disinfectant, medical devices
Public Device Record Key
5dd74fb5-83d2-4860-bc2a-b5324fb1f117
Public Version Date
March 19, 2021
Public Version Number
5
DI Record Publish Date
April 28, 2017
Package DI Number
10889813003852
Quantity per Package
4
Contains DI Package
00889813003855
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1457 |
2 | A medical device with a moderate to high risk that requires special controls. | 194 |
U | Unclassified | 2 |