Duns Number:012430880
Device Description: Essentials LED Curing Light, Silver
Catalog Number
1126233
Brand Name
Henry Schein
Version/Model Number
1126233
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBZ
Product Code Name
ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Public Device Record Key
215743e0-8a46-4eba-b05e-2c56f27fd25f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 09, 2017
Package DI Number
10304040054267
Quantity per Package
15
Contains DI Package
00304040054260
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |