FDA.reportPublic FDA data

VESALIUS Molecular Resonance Generator

Primary DI
08034055291184
Brand
VESALIUS Molecular Resonance Generator
Company
TELEA ELECTRONIC ENGEENERING SRL
Model
VESALIUS QUANTUM
Catalog number
2501019
Published
2019-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034055298190PackageGS11In Commercial Distribution
08034055291184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034055298190080340552981908034055298190
08034055291184080340552911848034055291184

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435331459
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034055295861VESALIUS STERILE footswitch handle with ballSterile, L=3m25020192016-09-24
08034055293850VESALIUS STERILE single-use endoscopic probe for ablationSTERILE26100042016-09-24
08034055291276VESALIUS Molecular Resonance GeneratorVESALIUS ESSENTIAL25010292019-11-11
08034055295755VESALIUS STERILE Short fingerswitch handleSterile, L=3m25020182016-09-24
08034055296738VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232019-11-11
08034055290224VESALIUs Footswitch handleReusable, L=3m25020012016-09-24
08034055290231VESALIUS Fingerswitch handleReusable, L=3m 25020032016-09-24
08034055290255VESALIUS STERILE fingerswitch handleSterile, L=3m25020062016-09-24
08034055290309VESALIUS Fingerswitch handleReusable; L=5m 25020132016-09-24
08034055294628VESALIUS STERILE Short fingerswitch handleSterile, L=3m25020182016-09-24
08034055296752VESALIUS Molecular Resonance GeneratorVESALIUS QUANTUM25010192019-11-11
08034055296806VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232019-11-11
08034055290163VESALIUS Molecular Resonance GeneratorVESALIUS QUANTUM25010192016-09-24
08034055290200VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232016-09-24
08034055296059VESALIUS Molecular Resonance GeneratorVESALIUS ESSENTIAL25010292016-09-24
8034055297681VESALIUS STERILE single-use endoscopic probe for ablationSTERILE26100042016-09-24
08034055290361VESALIUS single-use neutral insulated plate for adultsSingle-use25030032016-09-24
08034055293157VESALIUS round bipolar connector for ESSENTIALL=3m2506007E2018-12-31
08034055298213VESALIUS Molecular Resonance GeneratorVESALIUS ESSENTIAL25010292019-11-11
08034055298206VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232019-11-11

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