GONIO ready® CL

GUDID 04049584034229

The GONIO ready® CL (Contact Lens) is a self-stabilizing, single-use, direct gonioscopy lens used to enable bimanual surgery inMinimally Invasive Glaucoma Surgery (MIGS) procedures. Intended for direct visualization of the anterior chamber angle andretention atop the cornea without manual stabilization of the lens. Indicated for diagnostic use during minimally invasive glaucomasurgery. The device is primarily used in conjunction with a surgical operating microscope in hospitals, surgery centers, clinics, andother medical institutions.

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Microscope objective

• Primary Device ID: 04049584034229
• NIH Device Record Key: a7bd4c24-9bcb-41e4-a466-3e27ee21ba61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GONIO ready® CL
• Version Model Number: 10012719
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584034212 [Primary]
GS1	04049584034229 [Package]; Contains: 04049584034212; Package: Cardboard box [10 Units]; In Commercial Distribution

FDA Product Code

• HKS: Prism, Gonioscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-19
• Device Publish Date: 2025-05-09

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

• 04049584037695 - Focusing Module BIOM 6, 175 mm: 2026-02-02
• 04049584037701 - Focusing Module BIOM 6, 200 mm: 2026-02-02
• 04049584037718 - Precision Mount for B&L: 2026-02-02
• 04049584037725 - Precision Mount for Leica: 2026-02-02
• 04049584037732 - Precision Mount for Alcon: 2026-02-02
• 04049584037749 - Precision Mount for Zeiss: 2026-02-02
• 04049584037756 - Precision Mount for Haag Streit: 2026-02-02
• 04049584035738 - BIOM 6 HD Optic Set for f=175 mm: 2026-01-22