Sinuscope SN0300140

GUDID B366SN0300140R000

Sinuscope 3mm Ø, 00°, 140mm L

Ecleris

Rigid sinoscope

• Primary Device ID: B366SN0300140R000
• NIH Device Record Key: e06a24ac-e09c-4f18-b902-b169c86305ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sinuscope
• Version Model Number: R00
• Catalog Number: SN0300140
• Company DUNS: 043555079
• Company Name: Ecleris
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@ecleris.com
• Phone: 7864837490
• Email: carlosb@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
• 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
• 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	B366SN0300140R000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131323

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

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: 2016-09-24

On-Brand Devices [Sinuscope]

• B366SN0470175R000: Sinuscope 4mm Ø, 70°, 175mm L
• B366SN0445175R000: Sinuscope 4mm Ø, 45°, 175mm L
• B366SN0430175R000: Sinuscope 4mm Ø, 30°, 175mm L
• B366SN0400175R000: Sinuscope 4mm Ø, 00°, 175mm L
• B366SN0370140R000: Sinuscope 3mm Ø, 70°, 140mm L
• B366SN0330140R000: Sinuscope 3mm Ø, 30°, 140mm L
• B366SN0300140R000: Sinuscope 3mm Ø, 00°, 140mm L
• B366SN117: SINUSCOPIO, 4 mm Ø , 70° , 185 mm HD
• B366SN116: SINUSCOPIO, 4 mm Ø, 30°, 185 mm HD
• B366SN115: SINUSCOPIO, 4 mm Ø , 0 °, 185 mm HD
• B366SN114: Sinuscope, 3mm Ø, 70°, 150mm L, autoclavable
• B366SN113: Sinuscope, 3mm Ø, 45°, 150mm L, autoclavable
• B366SN110: Sinuscope, 2.7mm Ø, 70°, 140mm L, Autoclavable
• B366SN109: Sinuscope, 2.7mm Ø, 30°, 140mm L, Autoclavable
• B366SN108: Sinuscope, 2.7mm Ø, 0°, 140mm L, Autoclavable
• B366SN106: Sinuscope, 2.7mm Ø, 30°, 195mm L, Autoclavable
• B366SN105: Sinuscope, 2.7mm Ø, 0°, 195mm L, Autoclavable
• B366SN104: Sinuscope, 4mm Ø, 70°, 185mm L, Autoclavable
• B366SN102: Sinuscope, 4mm Ø, 30°, 185mm L, Autoclavable
• B366SN101: Sinuscope, 4mm Ø, 00°, 185mm L, Autoclavable
• B366SN0470175: Sinuscope 4mm Ø, 70°, 175mm L
• B366SN0445175: Sinuscope 4mm Ø, 45°, 175mm L
• B366SN0430175: Sinuscope 4mm Ø, 30°, 175mm L
• B366SN0400175: Sinuscope 4mm Ø, 00°, 175mm L
• B366SN0370140: Sinuscope 3mm Ø, 70°, 140mm L
• B366SN0330140: Sinuscope 3mm Ø, 30°, 140mm L
• B366SN0300140: Sinuscope 3mm Ø, 00°, 140mm L