DEVICE: Easyfield C (04049584000057)

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Device Identifier (DI) Information

Easyfield C
15000

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
04049584000057
GS1
1
The OCULUS Easyfield® has been designed for combined use as a screening unit with all associated options for immediate follow-up examination of suspicious findings. The most common examination grids and strategies for the central visual field up to 30° can be accessed. The Easyfield® offers pre programmed combinations for often needed examination routines. For example: Screening 24-2, SPARK Quick, Macula. You can also combine your own routines and then save them as a program.
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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
Perimeter, automatic A mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters.
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FDA Product Code

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Product Code Product Code Name
HOO Perimeter, 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 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
Weight: 6.8 Kilogram
Height: 435 Millimeter
Depth: 540 Millimeter
Width: 316 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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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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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None
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Production Identifier(s) in UDI

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Yes CLOSE

Customer Contact

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No Customer Contact currently defined
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