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TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 3269.EB05
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- TotalView Chandelier for cannula system (25 gauge / 0.5 mm) EUDAMEDTotalView Chandelier for cannula system.(25 gauge / 0.5 mm) FDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- TotalView Chandelier for cannula system (25 gauge / 0.5 mm) EUDAMED
- Model / Reference
- 3269.EB05 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 3269.EB05 FDA UDI
- Primary DI / UDI-DI
- 08717872016931 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717872016931 EUDAMED
- 510(k) Number
- K062895 FDA UDI
- FDA Product Code
- MPA FDA UDI
- EMDN Code
- Z12129085 VARIOUS OPHTALMOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic fibreoptic light instrument, single-use
TotalView Chandelier for cannula system.(25 gauge / 0.5 mm) by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — MDD, FDA UDI…
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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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 4d12cc18-54b9-4dbb-b3b8-4f90dd4b58fb 34 fields · synced Oct 8, 2026
- EUDAMED cb2c4022-5f62-4823-980e-2c377efc24ec 61 fields · synced Oct 8, 2026