C-Test, Vision acuity test

GUDID 04049584006592

C-Test, Vision acuity test

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Vision testing/training chart

• Primary Device ID: 04049584006592
• NIH Device Record Key: 7c0b1a6a-19d8-4bd6-bc14-5469994dac59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Test, Vision acuity test
• Version Model Number: 47020
• Company DUNS: 317138956
• Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584006592 [Primary]

FDA Product Code

• HOX: Chart, Visual Acuity

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: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

• 04049584035738 - BIOM 6 HD Optic Set for f=175 mm: 2026-01-22
• 04049584035745 - BIOM 6 HD Optic Set for f=200 mm: 2026-01-22
• 04049584037152 - BIOM 6: 2026-01-22
• 04049584037251 - Twinfield 3: 2026-01-22
• 04049584034229 - GONIO ready® CL: 2025-05-19 The GONIO ready® CL (Contact Lens) is a self-stabilizing, single-use, direct gonioscopy lens used to enable bimanual surgery in
• 04049584029447 - BIOM ready+ 175, for f=175 mm: 2024-09-19 BIOM ready+ 175, for f=175 mm
• 04049584029454 - BIOM ready+ 200, for f=200 mm: 2024-09-19 BIOM ready+ 200, for f=200 mm
• 04049584001450 - BK 1/W, coated, wall version, trial lens case: 2024-09-12 BK 1/W, coated, wall version, trial lens case