Catalog Number

2501023

Brand Name

VESALIUS Molecular Resonance Generator

Version/Model Number

VESALIUS MCNplus

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 11, 2019

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"

-

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

13c26f45-4831-4cff-bdf4-4b7a82b1ed6d

Public Version Date

November 19, 2019

Public Version Number

1

DI Record Publish Date

November 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-