Identity
- Trade Name
- Disposable Flat Vitrectomy FDA UDI
- Generic Name
- Vitrectomy contact lens, single-use FDA UDI
- Model / Reference
- ODVF 12179 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238075213 FDA UDI
- 510(k) Number
- K012096 FDA UDI
- FDA Product Code
- HJK FDA UDI
- GMDN Term
- Vitrectomy contact lens, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1385 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vitrectomy contact lens, single-use
Disposable Flat Vitrectomy by Ocular Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PHAKOS — Phakos · Class II
- PHAKOS — Phakos · Class II
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ocular Instruments, Inc.
Sources (1)
- FDA UDI f0260964-f1c3-45fc-9db1-ff9e66cbdd59 33 fields · synced May 31, 2026