Duns Number:315830349
Device Description: CoCr laser welding wire 0.5 mm, round, 2 m length, on a coilFor safe welding of your CoCr CoCr laser welding wire 0.5 mm, round, 2 m length, on a coilFor safe welding of your CoCr technical dental work using the laser and plasma welding technique.
Catalog Number
-
Brand Name
CoCr laser welding wire 0.5 mm
Version/Model Number
687554
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 07, 2017
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
EJH
Product Code Name
Alloy, Metal, Base
Public Device Record Key
61890fd6-21c2-43f1-b847-1e4f91d8a228
Public Version Date
June 17, 2019
Public Version Number
3
DI Record Publish Date
January 30, 2017
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 |