Identity
- Trade Name
- GONIO ready® CL FDA UDI
- Generic Name
- Microscope objective FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 10012719 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 10012720 FDA UDI
- Primary DI / UDI-DI
- 04049584034212 FDA UDI
- FDA Product Code
- HKS FDA UDI
- GMDN Term
- Microscope objective FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microscope objective
GONIO ready® CL by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microscope objective.
- Surgical Microscope MM90/YOH — MITAKA KOHKI CO., LTD. · Class I
- Surgical Microscope MM80/YOH — MITAKA KOHKI CO., LTD. · Class I
- Surgical Microscope MM51/SS1 — MITAKA KOHKI CO., LTD. · Class I
- Surgical Microscope MM90/SS1 — MITAKA KOHKI CO., LTD. · Class I
- Surgical Microscope MM51/SOH — MITAKA KOHKI CO., LTD. · Class I
- Surgical Microscope MM80/SOH — MITAKA KOHKI CO., LTD. · Class I
- Surgical 3D Video Microscope KestrelView II — MITAKA KOHKI CO., LTD. · Class I
- GONIO ready® 175 for f=175 — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI a7bd4c24-9bcb-41e4-a466-3e27ee21ba61 34 fields · synced May 30, 2026