FDA.reportPublic FDA data

Endovascular Laser Vein System (ELVeS®) Kit

Primary DI
04049089100283
Brand
Endovascular Laser Vein System (ELVeS®) Kit
Company
Ceram Optec SIA
Model
ELVeS® Radial® Kit 6Fx7cm
Catalog number
101235
Published
2017-01-31
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049089200280PackageGS15In Commercial Distribution
04049089100283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049089200280040490892002804049089200280
04049089100283040490891002834049089100283

GMDN Terms#

Term, Definition table
TermDefinition
Varicose vein lasing procedure kitA collection of sterile devices and materials designed to perform percutaneous laser treatment of varicose veins and varicosities associated with reflux in the superficial veins of the leg. It typically contains an entry needle, a laser fibre, an introducer sheath, a catheter, a guidewire, a dilator, and connectors to facilitate connection to a laser (e.g., a diode laser) and provide a pathway for the laser energy into the section(s) of the vein to be treated. This device does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
506069240
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049089100306MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, COH-G, noIDENT-24-COH-G2017-03-07
04049089100313MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, COH-H, noIDENT-24-COH-H2017-03-07
04049089100320MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, COH-S, noIDENT-24-COH-S2017-03-07
04049089100337MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, HGM-G, noIDENT-24-HGM-G2017-03-07
04049089100344MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, HGM-H, noIDENT-24-HGM-H2017-03-07
04049089100351MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, HGM-S, noIDENT-24-HGM-S2017-03-07
04049089100368MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, SMA-G, noIDENT-24-SMA-G2017-03-07
04049089100375MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, SMA-H, noIDENT-24-SMA-H2017-03-07
04049089100382MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, SMA-S, noIDENT-24-SMA-S2017-03-07
04049089100399MegaBeam® Reusable Fiber Optic Delivery SystemMegaBeam® Reusable Bare Fiber 230um, Flat Tip, noI1011352017-01-31
04049089100405MegaBeam® Reusable Fiber Optic Delivery SystemMegaBeam® Reusable Bare Fiber 365um, Flat Tip, noI1011452017-01-31
04049089100412MegaBeam® Reusable Fiber Optic Delivery SystemMegaBeam® Reusable Bare Fiber 550um, Flat Tip, noI1011552017-01-31
04049089100429MegaBeam® Reusable Fiber Optic Delivery SystemMegaBeam® Reusable Bare Fiber 1000um, Flat Tip, no1011652017-01-31
04049089100474MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 600um, Flat Tip PF1010152017-03-07
04049089100481MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 1000um, Flat Tip F1010352017-03-07
04049089100498MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 600um, Flat Tip FT1010402017-03-07
04049089100504MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 400um, Flat Tip, I1010452017-03-07
04049089100511MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 1000um, Flat Tip, 1010902017-03-07
04049089100528MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 600um, Flat Tip, I1010952017-03-07
04049089100535MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 230um, Flat Tip, I1011302017-03-07

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