Duns Number:315830349
Device Description: Brightener for classic EL-Form Galvano system, for activation of the Galvano bath and to a Brightener for classic EL-Form Galvano system, for activation of the Galvano bath and to achieve an even build-up of coats.
Catalog Number
-
Brand Name
EL-FORM Brightener, 50 ml
Version/Model Number
625021
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 08, 2016
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
EJT
Product Code Name
Alloy, Gold-Based Noble Metal
Public Device Record Key
942ed3a7-b438-417e-b25b-1dc6b6744b62
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 13, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 390 |