MICROSCOPE U1OM100F19

GUDID B366U1OM100F19

MICROSCOPE

Ecleris

General-purpose surgical microscope

• Primary Device ID: B366U1OM100F19
• NIH Device Record Key: 5bc17a8c-3ec8-4b49-9334-b755ed1961ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICROSCOPE
• Version Model Number: R01
• Catalog Number: U1OM100F19
• Company DUNS: 043555079
• Company Name: Ecleris
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B366U1OM100F19 [Primary]

FDA Product Code

• EPT: Microscope, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-08
• Device Publish Date: 2022-06-30

On-Brand Devices [MICROSCOPE]

• B366U1OM100W9LR00: MICROSCOPE
• B366U1OM100W9: MICROSCOPE
• B366U1OM100W20LR00: MICROSCOPE
• B366U1OM100F2LR01: MICROSCOPE
• B366U1OM100F1LR01: MICROSCOPE
• B366U1OM100F19LR01: MICROSCOPE
• B366U1OM100F1: MICROSCOPE
• B366U1OM100C19LR00: MICROSCOPE
• B366U1OM100C18LR00: MICROSCOPE
• B366U1OM100W20: MICROSCOPE
• B366U1OM100W10LR00: MICROSCOPE
• B366U1OM100W10: MICROSCOPE
• B366U1OM100T19: MICROSCOPE
• B366U1OM100T18: MICROSCOPE
• B366U1OM100T17: MICROSCOPE
• B366U1OM100F2: MICROSCOPE
• B366U1OM100F19: MICROSCOPE
• B366U1OM100C19: MICROSCOPE
• U1OM200TRX1: MICROSCOPE
• U1OM200FRX1: MICROSCOPE
• U1OM200CRX1: MICROSCOPE
• U1OM200TLRX1: MICROSCOPE
• U1OM200FLRX1: MICROSCOPE
• U1OM200CLRX1: MICROSCOPE
• B366U1OM200WRX1: MICROSCOPE
• B366U1OM200WLRX1: MICROSCOPE
• B366U1OM200TRX1: MICROSCOPE
• B366U1OM200TLRX1: MICROSCOPE
• B366U1OM200FRX1: MICROSCOPE
• B366U1OM200FLRX1: MICROSCOPE
• B366U1OM200CRX1: MICROSCOPE
• B366U1OM200CLRX1: MICROSCOPE
• B366U1OM200FR00: MICROSCOPE
• B366U1OM200FLR00: MICROSCOPE
• B366U1OM200WR00: MICROSCOPE
• B366U1OM200WLR00: MICROSCOPE
• B366U1OM200TR00: MICROSCOPE
• B366U1OM200TLR00: MICROSCOPE
• B366U1OM200CR00: MICROSCOPE
• B366U1OM200CLR00: MICROSCOPE
• B366U1OM200WR01: MICROSCOPE
• B366U1OM200WLR01: MICROSCOPE
• B366U1OM200TR01: MICROSCOPE
• B366U1OM200TLR01: MICROSCOPE
• B366U1OM200CR01: MICROSCOPE
• B366U1OM200CLR01: MICROSCOPE
• B366U1OM200FR01: MICROSCOPE
• B366U1OM200FLR01: MICROSCOPE