MARCO

GUDID 04560323648472

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: 04560323648472
• NIH Device Record Key: 52c4df83-ea99-405a-a6f5-d2a091add54b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MARCO
• Version Model Number: MARCO ULTRA M3
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560323648472 [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