Duns Number:435331459
Catalog Number
2503003
Brand Name
VESALIUS single-use neutral insulated plate for adults
Version/Model Number
Single-use
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
857943cf-0845-4e3b-a3df-4755c6e6e0ea
Public Version Date
June 05, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
8034055298176
Quantity per Package
1
Contains DI Package
08034055290361
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 244 |