MARCO

GUDID 04560323648465

An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to t

TAKAGI SEIKO CO.,LTD.

Ophthalmic slit lamp, examination

Primary Device ID	04560323648465
NIH Device Record Key	af4386d5-ee3b-4cd0-aa0e-e3f5c2be1b66
Commercial Distribution Status	In Commercial Distribution
Brand Name	MARCO
Version Model Number	MARCO ULTRA M4
Company DUNS	690907167
Company Name	TAKAGI SEIKO CO.,LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560323648465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162636

FDA Product Code

HJO	Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-04-25

On-Brand Devices [MARCO]

06909071678474	MARCO ULTRAM3
06909071678467	MARCO ULTRA M4
06909071678450	MARCO ULTRA MAX2
06909071678443	MARCO ULTRA MAX5
06909071678436	MARCO ULTRA M2
06909071678429	MARCO ULTRA M5
06909071671222	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
06909071671215	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
06909071671192	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
06909071671185	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
06909071671178	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
06909071671161	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
06909071671147	MARCO DELUXE２ STAND
06909071671130	MARCO NON CONSOLE DELUXE２ STAND
06909071671109	MARCO TRIAL LENS FRAME
06909071671086	MARCO BRAVO CHAIR
06909071671079	MARCO TILT CHAIR
06909071671055	MARCO ENCORE AUTOMATIC CHAIR
06909071671048	MARCO ENCORE MANUAL CHAIR
04560323649127	MARCO DELUXE 2 STAND
04560323649110	MARCO NON-CONSOLE DELUXE 2 STAND
04560323649103	MARCO ENCORE STAND
04560323649035	MARCO BRAVO CHAIR
04560323649028	MARCO TILT CHAIR
04560323649011	MARCO ENCORE AUTOMATIC CHAIR
04560323649004	MARCO ENCORE MANUAL CHAIR
04560323648908	MARCO TRIAL LENS FRAME
04560323648601	MARCO SURGISCOPE 3
04560323648526	MARCO AT-8 APPLANATION TONOMETER
04560323648502	MARCO AT-9 APPLANATION TONOMETER
04560323648472	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
04560323648465	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
04560323648434	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
04560323648427	An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the
04560323648137	MARCO ORION OPHTHALMIC WORKSTATION
04560323649158	MARCO BRAVO STAND
04560323649165	MARCO DELUXE STAND
04560323640940	MARCO ULTRA M2 BI

Trademark Results [MARCO]

Mark Image Registration \| Serial	Company Trademark Application Date
MARCO 98759226 not registered Live/Pending	AI Collaborator, Inc. 2024-09-19
MARCO 98688362 not registered Live/Pending	AXUS Stationery (Shanghai) Co., Ltd. 2024-08-08
MARCO 98555808 not registered Live/Pending	KLD IP Holdings, LLC 2024-05-17
MARCO 98375974 not registered Live/Pending	Marco Global Payroll Pte. Ltd. 2024-01-25
MARCO 98251995 not registered Live/Pending	James Briggs 2023-11-02
MARCO 98000107 not registered Live/Pending	Marco Specialties, Inc. 2023-05-17
MARCO 97815840 not registered Live/Pending	Marco N.P.K., Inc. 2023-02-28
MARCO 97786167 not registered Live/Pending	Marco Technologies, LLC 2023-02-08
MARCO 97766768 not registered Live/Pending	Ron N Zeligzon 2023-01-24
MARCO 97660318 not registered Live/Pending	QualiTech Environmental, Inc. 2022-11-02
MARCO 97570424 not registered Live/Pending	Unistrut International Corporation 2022-08-30
MARCO 97567466 not registered Live/Pending	BARKSDALE, BRANDON 2022-08-26