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Illuminated infusion cannula, 1.2 mm.
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Illuminated infusion cannula, 1.2 mm. FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use FDA UDI
- Model / Reference
- 3269.D1D FDA UDI
Identifiers
- Catalog Number
- 3269.D1D FDA UDI
- Primary DI / UDI-DI
- 08717872009421 FDA UDI
- 510(k) Number
- K062895 FDA UDI
- FDA Product Code
- MPA FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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: Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use
Illuminated infusion cannula, 1.2 mm. by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use.
- iTrack Advance — Nova Eye, Inc. · Class I
Cleared under the same submission
K062895 also covers:
- 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidan — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge / — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge / — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Chandelier fiber (one fiber) with Photon connector and guidance needl — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Chandelier fiber (one fiber) with Photon connector and guidance needl — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gauge — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gauge — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
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
Sources (1)
- FDA UDI e17f5945-cc29-483d-accb-1098b1e28ce8 34 fields · synced May 30, 2026