FDA.report

VESALIUS Micro EVO NON STICK bipolar forceps

Primary DI
08034055290996
Brand
VESALIUS Micro EVO NON STICK bipolar forceps
Company
TELEA ELECTRONIC ENGEENERING SRL
Model
Reusable, L=200mm T=0,25mm
Catalog number
2606330
Published
2019-09-21
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

Related Records

Product Codes

CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08034055290996PrimaryGS10

GMDN Terms

TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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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
08034055291009VESALIUS Micro EVO NON STICK bipolar forcepsReusable, L=250mm T=1mm26063312019-09-21

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