GUDID 04250480107614

Controller Full HD

SCHÖLLY FIBEROPTIC GmbH

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera

• Primary Device ID: 04250480107614
• NIH Device Record Key: 3cab1ee2-1486-4a44-9838-ad5effc811cf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 95-3910
• Company DUNS: 316276682
• Company Name: SCHÖLLY FIBEROPTIC GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com
• Phone: 9999999999
• Email: info@schoelly-usa.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250480107614 [Primary]

FDA Product Code

• FWF: Camera, Television, Endoscopic, Without Audio
• GJC: Assay, Sulfhemoglobin

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: 2019-03-11
• Device Publish Date: 2019-02-15

Devices Manufactured by SCHÖLLY FIBEROPTIC GmbH

• 04250480102329 - NA: 2023-11-07 Laparoscope 5 x 312 mm, 0°
• 04250480102336 - NA: 2023-11-07 Laparoscope 5 x 312 mm, 30°
• 04250480109038 - NA: 2023-11-07 NIR FI Light Guide, 4.8 x 3000 mm
• 04250480109052 - NA: 2023-11-07 Laparoscope 10 x 344 mm, 0°, NIR
• 04250480109069 - NA: 2023-11-07 Laparoscope 10 x 344 mm, 30°, NIR
• 04250480109076 - NA: 2023-11-07 NIR FI Camera Head Full HD Zoom
• 04250480109083 - NA: 2023-11-07 NIR FI CCU Full HD
• 04250480109045 - N/A: 2023-11-01 NIR FI Light Source