GUDID 04250480101063

Laparoscope 2 x 258 mm, 30º

SCHÖLLY FIBEROPTIC GmbH

Rigid optical laparoscope

• Primary Device ID: 04250480101063
• NIH Device Record Key: b6757081-bf95-41d5-8d80-667aa03c8aaf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 11.0475a
• Company DUNS: 316276682
• Company Name: SCHÖLLY FIBEROPTIC GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 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	04250480101063 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[04250480101063]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-05

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