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OLV-1-4P Landers Four Post Vitrectomy Lens Ring
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5961
Identity
- Trade Name
- OLV-1-4P Landers Four Post Vitrectomy Lens Ring EUDAMEDLanders Four Post Vitrectomy Lens Ring FDA UDI
- Generic Name
- Vitrectomy sutureless lens holding ring, reusable FDA UDI
- Device Name
- Contact Ophthalmic EUDAMED
- Model / Reference
- 5961 EUDAMEDOLV-1-4P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238059619 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262637 EUDAMED
- 510(k) Number
- K912268 FDA UDI
- FDA Product Code
- HNH FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Vitrectomy sutureless lens holding ring, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
OLV-1-4P Landers Four Post Vitrectomy Lens Ring by Ocular Instruments, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 06302381262637 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ocular Instruments Inc.
- EUDAMED SRN
- US-MF-000007216
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9feb40d0-0324-4110-87cf-1a55a92604f7 61 fields · synced Jul 21, 2026
- FDA UDI de7e80c3-92a9-444f-b4ff-244674fd9ea2 33 fields · synced May 30, 2026