GUDID 04250480107997

Camera Head Full HD autoclavable

SCHÖLLY FIBEROPTIC GmbH

Endoscope video camera

• Primary Device ID: 04250480107997
• NIH Device Record Key: 5282e21a-c8db-4997-aed8-3230fcca1f95
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 95-3904
• 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
• 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 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
• 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
• 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	04250480107997 [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

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

[04250480107997]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-28
• Device Publish Date: 2020-08-20

Devices Manufactured by SCHÖLLY FIBEROPTIC GmbH

• 04250480105603 - NA: 2024-09-20 Sealing caps, 10 pcs. pack, for instrument channel
• 04250480105979 - NA: 2024-09-20 Three-slot membrane,10 pcs. pack, for instrument bridge
• 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