Identity
- Trade Name
- ALCON FDA UDI
- Generic Name
- Ophthalmic cannulation set, single-use FDA UDI
- Device Name
- 27GA High Performance Valved Entry System, 4 mm 1 Count FDA UDI
- Model / Reference
- 00380650003560 FDA UDI
- Description
- 27GA High Performance Valved Entry System, 4 mm 1 Count FDA UDI
Identifiers
- Catalog Number
- 8065000356 FDA UDI
- Primary DI / UDI-DI
- 00380650003560 FDA UDI
- FDA Product Code
- NGY FDA UDI
- GMDN Term
- Ophthalmic cannulation set, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Category: Ophthalmic cannulation set, single-use
Alcon by Alcon Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic cannulation set, single-use.
- Disposable One Step Cannula System (25 gauge/0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Surgeon's Choice Card — OASIS Medical, Inc. · Class I
- MANI Trocar Kit — MANI, INC. · Class I
- Kaiser Permanente Kit Pack — OASIS Medical, Inc. · Class I
- 23G Cannula set with High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Disposable one step single cannula including inserter. (27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Kaiser Permanente Kit Pack — OASIS Medical, Inc. · Class I
- 25G High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI 11bd9666-b4d2-441b-99f6-3f32474d5db6 34 fields · synced Jun 8, 2026