Otoscope OT0300100

GUDID B366OT0300100

Otoscope 3mm Ø, 00°, 100mm L

Ecleris

Otoscope, endoscopic

• Primary Device ID: B366OT0300100
• NIH Device Record Key: 64265793-3815-4b62-84eb-ba1f5d76e79b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otoscope
• Version Model Number: R00
• Catalog Number: OT0300100
• 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
• 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
• Phone: 786-483-7490
• Email: ytzielo@ecleris.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 19 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B366OT0300100 [Primary]

FDA Product Code

• ERA: Otoscope

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: 2023-08-28
• Device Publish Date: 2023-08-18

On-Brand Devices [Otoscope]

• B366OT0330100R000: Otoscope 3mm Ø, 30°, 100mm L
• B366OT0300100R000: Otoscope 3mm Ø, 00°, 100mm L
• B366OT106: Otoscope, 4 mm Ø, 0°, 50 mm
• B366OT105: Otoscope, 1.9 mm Ø, 30°, 100 mm
• B366OT104: Otoscope, 1.9 mm Ø, 0°, 100 mm
• B366OT102: Otoscope, 2,7mm Ø, 30°, 75mm
• B366OT101: Otoscope, 2,7mm Ø, 0°, 75mm L
• B366OT0330100: Otoscope 3mm Ø, 30°, 100mm L
• B366OT0300100: Otoscope 3mm Ø, 00°, 100mm L