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OPV-S Pediatric Vitrectomy Lens Set
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 670510(k) K914051
Identity
- Trade Name
- OPV-S Pediatric Vitrectomy Lens Set EUDAMEDPediatric Vitrectomy Lens Set FDA UDI
- Generic Name
- Vitrectomy contact lens, reusable FDA UDI
- Device Name
- Contact Ophthalmic EUDAMED
- Model / Reference
- 670 EUDAMEDOPV-S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238006705 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262637 EUDAMED
- 510(k) Number
- K864418 FDA UDI
- FDA Product Code
- HJK FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Vitrectomy contact lens, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1385 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
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
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
OPV-S Pediatric Vitrectomy Lens Set by Ocular Instruments, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914051 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 06302381262637 | Class I | Active |
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Manufacturer
- Manufacturer
- Ocular Instruments Inc.
- EUDAMED SRN
- US-MF-000007216
- FDA Applicant
- Ocular Instruments, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED aa5619ef-0199-417c-b95c-6856bba5bbec 85 fields · synced Jun 18, 2026
- FDA UDI d469490c-bce8-46ae-bbe8-f41bffe880d6 33 fields · synced May 30, 2026
- FDA 510(k) K914051 1 fields · synced May 18, 2026