VESALIUS Molecular Resonance Generator - TELEA ELECTRONIC ENGEENERING SRL

Duns Number:435331459

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More Product Details

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

September 24, 2016

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

ff4bc91d-ec55-4a91-86eb-25496c1a7a0e

Public Version Date

November 15, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TELEA ELECTRONIC ENGEENERING SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 244