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1cc syringe holder for micro-injection
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- 1cc syringe holder for micro-injection FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Model / Reference
- 1364.DD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717872033051 FDA UDI
- 510(k) Number
- K213467 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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, non-illuminating, single-use
1cc syringe holder for micro-injection by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
- Lasik Irrigator - 4 Ports — Hurricane Medical · Class I
Cleared under the same submission
K213467 also covers:
- 23G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 25G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 25G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 27G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 27G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- 926823G Two Dimensional Cutter – 20k CPM — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Directional Laser Probe with DORC connector.(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 0f562b48-c8ef-4e65-893f-902361c725b3 33 fields · synced May 30, 2026