Ultrasound Biomicroscope

GUDID 06948941132005

MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.

Meda Co., Ltd

Ophthalmic ultrasound imaging system
Primary Device ID06948941132005
NIH Device Record Key2c9862c6-2b95-4422-97fd-828eb275df21
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasound Biomicroscope
Version Model NumberMD-320W
Company DUNS545188828
Company NameMeda Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106948941132005 [Primary]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-27
Device Publish Date2021-12-18

Devices Manufactured by Meda Co., Ltd

06948941132005 - Ultrasound Biomicroscope2021-12-27MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.
06948941132005 - Ultrasound Biomicroscope2021-12-27 MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It is intended to be used in clinical oph
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06948941111123 - Ultrasonic Biometer for Ophthalmology2018-04-25 MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s int
06948941102213 - Ultrasonic A/B Scanner for Ophthalmology2018-03-29 ODM-2100 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrason
06948941102220 - Ultrasonic A/B Scanner for Ophthalmology2018-03-29 ODM-2200 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrason
06948941102237 - Ultrasonic A/B Scanner for Ophthalmology2018-03-29 MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrason
06948941111109 - Ultrasonic Biometer for Ophthalmology2018-03-29 MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s inten

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