Identity
- Trade Name
- ULTRA FLOW FDA UDI
- Generic Name
- Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
- Device Name
- ULTRAFLOW S/P STRAIGHT TIP, .3MM FDA UDI
- Model / Reference
- 00380658170011 FDA UDI
- Description
- ULTRAFLOW S/P STRAIGHT TIP, .3MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380658170011 FDA UDI
- FDA Product Code
- NKK FDA UDI
- GMDN Term
- Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ultra Flow 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 a42ffb9e-23c4-438c-85e9-d9ade85382dd 34 fields · synced Jun 8, 2026