DEVICE: Ultrasonic Biometer for Ophthalmology (06948941111123)

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Device Identifier (DI) Information

Ultrasonic Biometer for Ophthalmology
MD-1000A/P

Meda Co., Ltd
06948941111123
GS1
1
MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters and corneal thickness.
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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
Ultrasound pachymeter A mains electricity (AC-powered), ophthalmic device that uses ultrasound to measure the thickness of the cornea. A small ultrasound probe that is connected to this device is placed directly onto the cornea to make the measurements which are recorded and displayed by the pachymeter. This line-powered device, also known as a pachometer, may provide print-out readings. The data is used to evaluate, e.g., refractive eye surgery (e.g., laser assisted in situ keratomileusis (LASIK) treatment), monitor epithelium regrowth and other ophthalmic needs.
Ophthalmic ultrasound imaging system An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.
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FDA Product Code

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Product Code Product Code Name
ITX Transducer, Ultrasonic, Diagnostic
IYO System, Imaging, Pulsed Echo, Ultrasonic
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Sterilization

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Sterilization Method [?]
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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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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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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