FDA.reportPublic FDA data

VESALIUS STERILE single-use endoscopic probe for ablation

Primary DI
08034055293850
Brand
VESALIUS STERILE single-use endoscopic probe for ablation
Company
TELEA ELECTRONIC ENGEENERING SRL
Model
STERILE
Catalog number
2610004
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
8034055297681PackageGS15In Commercial Distribution
08034055293850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8034055297681080340552976818034055297681
08034055293850080340552938508034055293850

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe, denervation, monopolar, single-useA hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under external image guidance or using electrical stimulation for nerve location] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula or a tubing set to allow fluid cooling of the electrode may be included. This is a single-use device.

Regulatory Flags#

DUNS number
435331459
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034055295861VESALIUS STERILE footswitch handle with ballSterile, L=3m25020192016-09-24
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
08034055298213VESALIUS Molecular Resonance GeneratorVESALIUS ESSENTIAL25010292019-11-11
08034055298206VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232019-11-11

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