Identity
- Trade Name
- Alcon FDA UDI
- Generic Name
- Vitrectomy system handpiece FDA UDI
- Device Name
- 25 GA Sclerotomy/Infusion 3.2mm Set; Contains (25 GA) sew-on Infusion Cannula, Scleral Plugs, and EDGEPLUS® Blade FDA UDI
- Model / Reference
- 8065751706 FDA UDI
- Description
- 25 GA Sclerotomy/Infusion 3.2mm Set; Contains (25 GA) sew-on Infusion Cannula, Scleral Plugs, and EDGEPLUS® Blade FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657517060 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Vitrectomy system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Commercial Distribution
- Not 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
Alcon by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI fe1f7c9f-bf96-4116-b25a-39266359a455 36 fields · synced Jun 6, 2026