Identity
- Trade Name
- UNIPURE & UNIFEYE FDA UDI
- Generic Name
- Perfluoropropane refillable cylinder FDA UDI
- Device Name
- UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments. FDA UDI
- Model / Reference
- 8065753066 FDA UDI
- Description
- UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments. FDA UDI
Identifiers
- Catalog Number
- 8065753066 FDA UDI
- Primary DI / UDI-DI
- 00380657530663 FDA UDI
- FDA Product Code
- LPO FDA UDI
- GMDN Term
- Perfluoropropane refillable cylinder FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.4270 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: Perfluoropropane refillable cylinder
Unipure & Unifeye by Alcon Laboratories, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Perfluoropropane refillable cylinder.
- UNIPURE & UNIPEXY — Alcon Laboratories, Inc. · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI c7a790ae-bae5-47d5-9f20-d3bd1880cbce 34 fields · synced Jun 1, 2026