DEVICE: VISULAS Trion (04049471091229)

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Device Identifier (DI) Information

VISULAS Trion
VISULAS Trion, VISULAS Trion VITE

Carl Zeiss Meditec AG
04049471091229
GS1
1
The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of ocular tissues for the treatment of diseases of the eye, such as: * Photocoagulation of the retina * Trabeculoplasty for treatment of glaucoma * Iridotomy for treatment of glaucoma. The VISULAS Trion Laser System with the VITE option is intended for use in multispot retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including: * Proliferative and nonproliferative diabetic retinopathy * Macular edema * Branch and central retinal vein occlusion * Lattice degeneration * Retinal tears and detachments * Choroidal neovascularization associated with wet age-related macular degeneration.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Ophthalmic solid-state laser system, photocoagulation/photostimulation A mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended for: 1) ocular photocoagulation procedures (e.g., coagulate abnormal vascular tissue in the retina); and/or 2) dosimetery-controlled photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It typically includes a light source and controls/foot-switch, and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors; it may include a dosimetry sensor. It does not include femtosecond pulsing or fundus imaging technology.
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FDA Product Code

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Product Code Product Code Name
GEX Powered Laser Surgical Instrument
HQF Laser, Ophthalmic
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Sterilization

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

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Storage and Handling
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Laser console dimensions with handles and rollers H x W x D 780 x 380 x 670 mm
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Device Status

In Commercial Distribution
September 20, 2016

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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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