FDA.reportPublic FDA data

MARCO

Primary DI
04560323648472
Brand
MARCO
Company
TAKAGI SEIKO CO.,LTD.
Model
MARCO ULTRA M3
Device description
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capusule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.
Published
2017-04-25
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
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162636000Marco Ultra M3, Marco Ultra M4Takagi Seiko Co., Ltd.2017-04-14HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560323648472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560323648472045603236484724560323648472

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690907167
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560323640940MARCOMARCO ULTRA M2 BI2024-03-14
04560323649165MARCOMARCO DELUXE STAND2023-09-08
04560323640902TAKAGIChart Projector CP-402023-06-09
04560323641114TAKAGISlitlamp Microscope 2ZL2023-06-09
04560323641121TAKAGISlitlamp Microscope 700GL2023-06-09
04560323641176TAKAGISlitlamp Microscope 30GL2023-06-09
04560323641183TAKAGISlitlamp Microscope 4ZL2023-06-09
04560323643804TAKAGIPROJECTION PERIMETER MT 325UD2023-06-09
04560323648564TAKAGIAT-12023-06-09
04560323649158MARCOMARCO BRAVO STAND2023-06-09
04560323641138TAKAGIMobile Slit lamp MS12021-12-06
04560323648427MARCOMARCO ULTRA M52017-04-26
04560323648434MARCOMARCO ULTRA M22017-04-25
04560323648465MARCOMARCO ULTRA M42017-04-25
06909071671161MARCOMARCO G4 ULTRA SLITLAMP2016-08-23
06909071671178MARCOMARCO ULTRA2016-07-22
06909071671185MARCOMARCO 5 ULTRA SLITLAMP2016-08-26
06909071671192MARCOMARCO 2B ULTRA SLITLAMP2016-08-26
06909071671215MARCOMARCO G2 ULTRA SLITLAMP2016-08-26
06909071671222MARCOMARCO G5 ULTRA SLITLAMP2016-08-26

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