FDA.reportPublic FDA data

VESALIUs Footswitch handle

Primary DI
08034055290224
Brand
VESALIUs Footswitch handle
Company
TELEA ELECTRONIC ENGEENERING SRL
Model
Reusable, L=3m
Catalog number
2502001
Published
2016-09-24
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
08034055290224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034055290224080340552902248034055290224

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
435331459
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21