Duns Number:009900424
Device Description: Curing Lens for Aurora™ D540 (Pkg. of 10 pcs.)
Catalog Number
D541
Brand Name
Aurora™
Version/Model Number
D541
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2019
Issuing Agency
In HIBCC
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)
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
de90e49d-417a-400b-a47c-49765cab5f4d
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
M595D5411
Quantity per Package
10
Contains DI Package
M595D5410
Package Discontinue Date
January 01, 2019
Package Status
Not 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |