Duns Number:012430880
Device Description: MAXIMA RU1200 CURING LIGHT
Catalog Number
1126227
Brand Name
Henry ScheinMaxima
Version/Model Number
1126227
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
51c7a9d2-4657-4d80-8971-3cd1642341d5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 21, 2017
Package DI Number
10304040054236
Quantity per Package
12
Contains DI Package
00304040054239
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 |