GUDID 04250480108000

Camera Head 4K UHD Zoom

SCHÖLLY FIBEROPTIC GmbH

Endoscope video camera

• Primary Device ID: 04250480108000
• NIH Device Record Key: cabce0f3-8d59-4e44-9b46-76e91d0722eb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 95-3905
• 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 Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 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
GS1	04250480108000 [Primary]

FDA Product Code

• FWF: Camera, Television, Endoscopic, Without Audio
• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

[04250480108000]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

Devices Manufactured by SCHÖLLY FIBEROPTIC GmbH

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• 04250480100288 - NA: 2025-01-23 Adapter light guide, Olympus light source
• 04250480100295 - NA: 2025-01-23 Adapter light guide, Wolf light source
• 04250480100325 - NA: 2025-01-23 Adapter light guides, ACMI light source
• 04250480100349 - NA: 2025-01-23 Adapter light guide, Storz endoscope
• 04250480100356 - NA: 2025-01-23 Adapter light guide, Wolf Endoscope
• 04250480100363 - NA: 2025-01-23 Adapter light guide, ACMI endoscope
• 04250480101759 - NA: 2025-01-23 Laparoscope 10 x 344mm, 0° RL-100