FDA.reportPublic FDA data

VESALIUS Molecular Resonance Generator

Primary DI
08034055298213
Brand
VESALIUS Molecular Resonance Generator
Company
TELEA ELECTRONIC ENGEENERING SRL
Model
VESALIUS ESSENTIAL
Catalog number
2501029
Published
2019-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08034055298213PackageGS11In Commercial Distribution
08034055291276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034055298213080340552982138034055298213
08034055291276080340552912768034055291276

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08034055291184VESALIUS Molecular Resonance GeneratorVESALIUS QUANTUM25010192019-11-11
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
08034055298206VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232019-11-11

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