FDA.report

VESALIUS STERILE footswitch handle with ball

Primary DI
08034055295861
Brand
VESALIUS STERILE footswitch handle with ball
Company
TELEA ELECTRONIC ENGEENERING SRL
Model
Sterile, L=3m
Catalog number
2502019
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08034055295861PrimaryGS10

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
435331459
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
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
8034055297681VESALIUS STERILE single-use endoscopic probe for ablationSTERILE26100042016-09-24
08034055291184VESALIUS Molecular Resonance GeneratorVESALIUS QUANTUM25010192019-11-11
08034055298213VESALIUS Molecular Resonance GeneratorVESALIUS ESSENTIAL25010292019-11-11
08034055298206VESALIUS Molecular Resonance Generator VESALIUS MCNplus 25010232019-11-11
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
08034055290958VESALIUS Micro EVO NON STICK bipolar forcepsReusable,L=165mm T=0,25mm26063262019-09-21
08034055290965VESALIUS Micro EVO NON STICK bipolar forcepsReusable, L=165mm T=0,6mm26063272019-09-21
08034055290972VESALIUS Micro EVO NON STICK bipolar forcepsReusable,L=180mm T=0,25mm26063282019-09-21
08034055290989VESALIUS Micro EVO NON STICK bipolar forcepsReusable, L=180mm T=0,6mm26063292019-09-21
08034055290996VESALIUS Micro EVO NON STICK bipolar forcepsReusable, L=200mm T=0,25mm26063302019-09-21
08034055291009VESALIUS Micro EVO NON STICK bipolar forcepsReusable, L=250mm T=1mm26063312019-09-21

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