FDA.reportPublic FDA data

MARCO

Primary DI
06909071671109
Brand
MARCO
Company
TAKAGI SEIKO CO.,LTD.
Model
MARCO TRIAL LENS FRAME
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HPAFrame, Trial, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPAFrame, Trial, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06909071671109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909071671109069090716711096909071671109

GMDN Terms#

Term, Definition table
TermDefinition
Electrical logic circuit meterAn instrument intended to be used to measure/log the signal path or course from logic circuits.

Storage And Handling#

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

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812559010559TF50 Trial FrameREICHERT, INC.HPA2025-08-12
00194613119744MSI Precision Specialty InstrumentsMed Saver, Inc.HPA2025-08-01
04547451333883Inami Ophthalmic InstrumentsINAMI & CO., LTD.HPA2025-05-28
04547451081722INAMI INAMI & CO., LTD.HPA2023-07-27
04049584007056Retinoscopy rack with sliderOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-07
04049584005656Half-eye Trial Frame for children, rigid nose bridgeOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
04049584005694Half-eye Trial Frame for children, adjustable nose pieceOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
04049584005717Universal Trial Frame UB 4OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
04049584005816Universal Trial Frame UB 5OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
04049584005823Half-eye Trial Frame, rigid nose bridgeOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
04049584005847Half-eye Trial Frame, adjustable nose pieceOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
04049584019394Universal Trial Frame UB 6OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
04049584019691Universal Trial Frame UB 3+OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
04049584019882Universal Trial Frame UB 4, ‘ESSILOR’ ESS304OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPA2022-12-02
00749590397168AlconAlcon Laboratories, Inc.HPA2021-10-19
00749590397175AlconAlcon Laboratories, Inc.HPA2021-10-19
04560323648908MARCOTAKAGI SEIKO CO.,LTD.HPA2017-04-25