FDA.reportPublic FDA data

Vari-Lase® Platinum Bright Tip laser fiber and procedure kits

Primary DI
M20671591
Brand
Vari-Lase® Platinum Bright Tip laser fiber and procedure kits
Company
Vascular Solutions, Inc.
Model
7159
Device description
The VARI-LASE Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity.
Published
2016-09-05
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

Contact Domains#

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
M20671591PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
888-240-6001customerservice@vasc.com

Regulatory Flags#

DUNS number
008999906
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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M20679640VSI StraitSet™ micro-introducer kit79602018-08-09
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M20674730VSI Tru-Torque™ guidewire74732016-09-05
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