Duns Number:435331459
Catalog Number
2603025
Brand Name
VESALIUS STERILE single-use tungsten round loop
Version/Model Number
STERILE, D=0,17mm d=12mm L=25mm
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"
Yes
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
fd32a2f8-24b9-4513-a878-353a523f98a5
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
8034055297322
Quantity per Package
10
Contains DI Package
08034055292242
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
DOUBLE ENVELOPE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 244 |