Identity
- Trade Name
- PERFLUORON FDA UDI
- Generic Name
- Aqueous/vitreous humour replacement medium kit FDA UDI
- Device Name
- PFNO KIT 5ML<USA Kit Contents: One 5 mL vial of sterile PERFLUORON Liquid One 10 mL syringe One 20 gauge beveled needle One 0.2 micron filter unit One 23 gauge blunt cannula One PERFLUORON Liquid package insert FDA UDI
- Model / Reference
- 0090010015 FDA UDI
- Description
- PFNO KIT 5ML<USA Kit Contents: One 5 mL vial of sterile PERFLUORON Liquid One 10 mL syringe One 20 gauge beveled needle One 0.2 micron filter unit One 23 gauge blunt cannula One PERFLUORON Liquid package insert FDA UDI
Identifiers
- Catalog Number
- 8065900163 FDA UDI
- Primary DI / UDI-DI
- 00380659001635 FDA UDI
- FDA Product Code
- LWL FDA UDI
- GMDN Term
- Aqueous/vitreous humour replacement medium kit FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.4275 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Aqueous/vitreous humour replacement medium kit
Perfluoron by Alcon Laboratories, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 III | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI a4e4c8ad-c906-4a00-815a-3369e876cdcf 36 fields · synced Jun 8, 2026