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Phaco needle, 30°, ø0.8 mm, with transparent REF: 3003.M sleeve.
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Phaco needle, 30°, ø0.8 mm, with transparent REF: 3003.M sleeve. FDA UDI
- Generic Name
- Phacoemulsification system handpiece FDA UDI
- Model / Reference
- 3005.FDM30 FDA UDI
Identifiers
- Catalog Number
- 3005.FDM30 FDA UDI
- Primary DI / UDI-DI
- 08717872009087 FDA UDI
- 510(k) Number
- K081877 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Phacoemulsification system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Phacoemulsification system handpiece
Phaco needle, 30°, ø0.8 mm, with transparent REF: 3003.M sleeve. by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI…
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Also classified as Phacoemulsification system handpiece.
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Cleared under the same submission
K081877 also covers:
- Associate Cartridge with upgraded infusion line / drip chamber. Suitable for ant — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Blue infusion sleeve for 3004.FD & 3006.PF phaco needles — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- DORC VFI connector between DORC System & 1363.DD — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Associate Cartridge.(including exchangeable I/A tubing and fluid givi — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Drapes, for Associate touch screen & remote control. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Eckardt One step Vitrectomy Kit.(23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable Fluid Giving set for Associate REF: 6279.ASD1 Cartridge incl connecto — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Cannula Pack for Associate (23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack for Associate (20 gauge / 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack for Associate (23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack. (20 gauge/ 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Disposable High Speed Vitrectomy Pack. (23 gauge/ 0.6 mm) — 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 5737bf6f-cc4c-4011-b011-5513e3fee6a5 34 fields · synced Jun 8, 2026