Identity
- Trade Name
- ISPAN FDA UDI
- Generic Name
- Vitreous/aqueous humour replacement medium, intraoperative FDA UDI
- Device Name
- ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances. FDA UDI
- Model / Reference
- 8065797102 FDA UDI
- Description
- ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657971022 FDA UDI
- PMA Number
- P900066 FDA UDI
- FDA Product Code
- LPO FDA UDI
- GMDN Term
- Vitreous/aqueous humour replacement medium, intraoperative 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
No
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
Dimensions & Sizes
- Size
- Weight — 125 Gram FDA UDI
Category: Vitreous/aqueous humour replacement medium, intraoperative
Ispan by Alcon Laboratories, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitreous/aqueous humour replacement medium, intraoperative.
- Ophthalin — Anika Therapeutics, Inc. · Class III
- ISPAN C3F8 Intraocular Gas — ESCALON MEDICAL CORP · Class III
- HEALON — Johnson & Johnson Surgical Vision, Inc. · Class III
- BVI Medical — Airgas Therapeutics · Class III
- BVI Medical — Airgas Therapeutics · Class III
- BVI Medical — Airgas Therapeutics · Class III
- HEALON ENDOCOAT PRO — Johnson & Johnson Surgical Vision, Inc. · Class III
- NuVisc — Anika Therapeutics, Inc. · Class III
Cleared under the same submission
P900066 also covers:
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 ed981e3f-95a7-411f-b324-ad55b57db42c 36 fields · synced Jun 8, 2026