Identity
- Trade Name
- Alcon, Engauge FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- 20 GA Curved Laser Probe - Chang Aspirating FDA UDI
- Model / Reference
- 8065750979 FDA UDI
- Description
- 20 GA Curved Laser Probe - Chang Aspirating FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657509799 FDA UDI
- FDA Product Code
- HQB FDA UDIHQE FDA UDIHQF FDA UDI
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4690 FDA UDI886.4150 FDA UDI886.4390 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, Engauge 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 f6673ed4-3cfc-408c-a8f1-42258c64ad64 36 fields · synced Jun 1, 2026