FDA.reportPublic FDA data

MARCO

Primary DI
06909071671048
Brand
MARCO
Company
TAKAGI SEIKO CO.,LTD.
Model
MARCO ENCORE MANUAL CHAIR
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
Single use
true

Product Codes#

Code, Name table
CodeName
HMDChair, Ophthalmic, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMDChair, Ophthalmic, ManualOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06909071671048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909071671048069090716710486909071671048

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic chair, line-poweredA mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).

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
00850020301522Haag-Streit SurgicalHAAG-STREIT USA, INC.HMD2024-01-03
07350136560101Carl MechanicalRini Ergoteknik ABHMD2023-08-18
07350136560200CarlRini Ergoteknik ABHMD2023-08-08
00850020301072RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301133RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301140RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301157RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301232RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301256RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301263RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301270RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301287RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301294RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301300RelianceHAAG-STREIT USA, INC.HMD2020-09-09
05050474617193CATALYS PATIENT CHAIRJOHNSON & JOHNSON SURGICAL VISION, INC.HMD2020-08-01
04560323649004MARCOTAKAGI SEIKO CO.,LTD.HMD2017-04-25