Duns Number:688201036
Device Description: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Catalog Number
-
Brand Name
Dr's Light
Version/Model Number
CL-DL10
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
K071908,K071908
Product Code
EBZ
Product Code Name
Activator, Ultraviolet, For Polymerization
Public Device Record Key
352827f7-8bc0-47b8-aec1-9d9083819ea9
Public Version Date
November 07, 2019
Public Version Number
1
DI Record Publish Date
October 30, 2019
Package DI Number
18800025400071
Quantity per Package
1
Contains DI Package
08800025400074
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 | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |
U | Unclassified | 2 |