FDA.reportPublic FDA data

Ultrasonic Biometer for Ophthalmology

Primary DI
06948941111123
Brand
Ultrasonic Biometer for Ophthalmology
Company
Meda Co., Ltd
Model
MD-1000A/P
Device description
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.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948941111123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948941111123069489411111236948941111123

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound pachymeterA mains electricity (AC-powered), ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth. A small ultrasound probe(s) that is connected to this device is placed directly onto the cornea to make the measurements which are recorded and displayed by the pachymeter. The data is used to evaluate refractive eye surgery [e.g., laser assisted in situ keratomileusis (LASIK) treatment], evaluate ocular measurements for calculating intraocular lens power, monitor epithelium regrowth, and for other ophthalmic measurement evaluations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545188828
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948941132005Ultrasound BiomicroscopeMD-320W2021-12-18
06948941160015Bladder ScannerMD-6000P2019-07-01
06948941111116Ultrasonic PachymeterMD-1000P2016-09-01
06948941102213Ultrasonic A/B Scanner for OphthalmologyODM-21002016-09-01
06948941102220Ultrasonic A/B Scanner for OphthalmologyODM-22002016-09-01
06948941102237Ultrasonic A/B Scanner for OphthalmologyMD-2300S 2016-09-01
06948941111109Ultrasonic Biometer for OphthalmologyMD-1000A2016-09-01
06948941160008Bladder ScannerMD-60002016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
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08056304455451MyLabA70ESAOTE SPAITX2025-07-07
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08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
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