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ISPAN C3F8 Intraocular Gas

FDA UDI

Class III (US FDA UDI)

by Escalon Medical Corp

Identity

Trade Name
ISPAN C3F8 Intraocular Gas FDA UDI
Generic Name
Vitreous/aqueous humour replacement medium, intraoperative FDA UDI
Device Name
ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum), and perfluoropropene 10 ppm (maximum). FDA UDI
Model / Reference
20 g Cylinder FDA UDI
Description
ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum), and perfluoropropene 10 ppm (maximum). FDA UDI

Identifiers

Catalog Number
TR9089 FDA UDI
Primary DI / UDI-DI
10860113000109 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vitreous/aqueous humour replacement medium, intraoperative

ISPAN C3F8 Intraocular Gas by Escalon Medical Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vitreous/aqueous humour replacement medium, intraoperative.

Cleared under the same submission

P900066 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Escalon Medical Corp

Sources (1)

  • FDA UDI bbdcf80e-2408-45b9-abfa-987041c4fa25 37 fields · synced Jun 1, 2026