DEVICE: Endovascular Laser Vein System (ELVeS®) Kit (04049089100290)

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Device Identifier (DI) Information

Endovascular Laser Vein System (ELVeS®) Kit
ELVeS® Radial® Slim Kit 4Fx11cm
101255
Ceram Optec SIA
04049089100290
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Varicose vein lasing procedure kit A 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.
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FDA Product Code

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Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 31, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04049089200297 5 04049089100290 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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