Duns Number:688201036
Device Description: Accessories of Dr's Light clever (CL-DC20)
Catalog Number
-
Brand Name
Battery_Drs Light Claver
Version/Model Number
CL0200110
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
K093751
Product Code
EBZ
Product Code Name
Activator, Ultraviolet, For Polymerization
Public Device Record Key
bb254534-4b7b-4a14-aeb1-da8d63447dfd
Public Version Date
December 02, 2019
Public Version Number
1
DI Record Publish Date
November 22, 2019
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 | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |
U | Unclassified | 2 |