FDA.reportPublic FDA data

TAKAGI

Primary DI
04560323643804
Brand
TAKAGI
Company
TAKAGI SEIKO CO.,LTD.
Model
PROJECTION PERIMETER MT 325UD
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOOPerimeter, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOOPerimeter, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560323643804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560323643804045603236438044560323643804

GMDN Terms#

Term, Definition table
TermDefinition
Perimeter, manualA mains electricity (AC-powered), manually-operated, diagnostic ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are displayed by manual operation in various random positions and patient response is recorded. A preprinted card (chart) is marked to show the resulting curve of the visual field. Such types include Goldmann perimeters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690907167
Device count
1
Premarket exempt
true
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
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
04560323648472MARCOMARCO ULTRA M32017-04-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049584037251Twinfield 3OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2026-01-14
04049584000040Twinfield 2OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2022-12-01
04049584000125Centerfield 2OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2022-12-01
04049584019363SmartfieldOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2022-11-30
04059237000372HEPHeidelberg Engineering GmbHHOO2018-07-11
04059237000396SPECTRALIS, HEPHeidelberg Engineering GmbHHOO2018-07-11
04057748085215Humphrey FDTCarl Zeiss Meditec, Inc.HOO2018-06-13
04057748085239Humphrey Matrix Carl Zeiss Meditec, Inc.HOO2018-06-13
04049584000057Easyfield COCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2016-09-01
04049584000064Easyfield SOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOO2016-09-01