DEVICE: Corvis STL (04049584014085)

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Device Identifier (DI) Information

Corvis STL
72300

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
04049584014085
GS1
1
The Corvis® ST is a non-contact tonometer equipped with an optical Pachymetry function. The Corvis® ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. During the air puff the eye gets illuminated by a 9 mm slit through the apex and a built-in high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera uses a sequence of 140 Scheimpflug images of the cornea which are analyzed by a built-in computer. Intra ocular pressure is determined by the detection of the applanation moments of the cornea.
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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 tonometer, battery-operated An ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients.
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FDA Product Code

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Product Code Product Code Name
HKX Tonometer, Ac-Powered
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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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
Weight: 14 Kilogram
Height: 520 Millimeter
Depth: 520 Millimeter
Width: 270 Millimeter
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Device Status

In Commercial Distribution
September 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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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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