FDA UDI
In Commercial Distribution
🇺🇸 United States
GONIO ready® CL
DI: 04049584034212
·
Model: 10012719
·
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GONIO ready® CL
- Primary DI
- 04049584034212
- Version / Model
- 10012719
- Catalog Number
- 10012720
- Company Name
- OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317138956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-09
- Public Version
- 2
- Public Version Date
- 2025-06-04
- Public Version Status
- Update
- Public Device Record Key
- a7bd4c24-9bcb-41e4-a466-3e27ee21ba61
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HKS | Prism, Gonioscopic | Ophthalmic | 886.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37184 | Microscope objective | A lens or lens group that forms the part of the optical system of a microscope closest to the object. It is used to magnify the viewed image. The objective may be supplied singularly, in pairs, or in sets of increasing magnification. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04049584034229 | GS1 | Cardboard box | 10 | In Commercial Distribution | |
| Primary | 04049584034212 | GS1 |