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OFVI Flat Vitrectomy Lens w/Infusion Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7408
Identity
- Trade Name
- OFVI Flat Vitrectomy Lens w/Infusion Handle EUDAMEDFlat Vitrectomy Lens w/Infusion Handle FDA UDI
- Generic Name
- Vitrectomy contact lens, reusable FDA UDI
- Device Name
- Contact Ophthalmic EUDAMED
- Model / Reference
- 7408 EUDAMEDOFVI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238074087 EUDAMEDFDA UDI
- Basic UDI-DI
- 06302381262637 EUDAMED
- Direct Marketing DI
- 00630238074049 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
OFVI Flat Vitrectomy Lens w/Infusion Handle by Ocular Instruments, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 b3879bc3-362e-45e7-a3db-0f2c968a4b76 61 fields · synced Jul 20, 2026
- FDA UDI fd7f727d-9a1a-458e-a628-157556d1b596 33 fields · synced May 30, 2026