Duns Number:315427286
Device Description: NiCr welding wire, ø 0,50 mm / length 2 m / for laser welding NiCr based alloys. Specific NiCr welding wire, ø 0,50 mm / length 2 m / for laser welding NiCr based alloys. Specifically for high grade alloys such as remanium® CS+, CSe and G-soft.
Catalog Number
-
Brand Name
N.A.
Version/Model Number
528-220-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
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
EJH
Product Code Name
ALLOY, METAL, BASE
Public Device Record Key
ccdef8e6-be79-4dba-8b2b-b859b678bd6d
Public Version Date
November 15, 2021
Public Version Number
3
DI Record Publish Date
September 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |