Ultrasonic Biometer for Ophthalmology

GUDID 06948941111109

MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of

Meda Co., Ltd

Ophthalmic ultrasound imaging system
Primary Device ID06948941111109
NIH Device Record Key0ed45f73-7ad0-4a2d-8dbf-15b3667c0e63
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasonic Biometer for Ophthalmology
Version Model NumberMD-1000A
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
GS106948941111109 [Primary]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

On-Brand Devices [Ultrasonic Biometer for Ophthalmology]

06948941111123MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based
06948941111109MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based o

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