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ISPAN SF6 Intraocular Gas

FDA UDI

Class III (US FDA UDI)

by Escalon Medical Corp

Identity

Trade Name
ISPAN SF6 Intraocular Gas FDA UDI
Generic Name
Vitreous/aqueous humour replacement medium, intraoperative FDA UDI
Device Name
ISPAN Sulfur Hexafluoride (SF6) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is a colorless, odorless, non-toxic, non-flammable gas. The boiling point is -63.9°C (-83°F) and the vapor pressure at 20°C is 320 psig (pounds per square inch gauge). ISPAN SF6 purity: sulfur hexafluoride 99.99% (minimum), air 100 ppm (maximum), carbon tetrafluoride 100 ppm (maximum), and hydrogen fluoride 0.3 ppm (maximum). FDA UDI
Model / Reference
20 g Cylinder FDA UDI
Description
ISPAN Sulfur Hexafluoride (SF6) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is a colorless, odorless, non-toxic, non-flammable gas. The boiling point is -63.9°C (-83°F) and the vapor pressure at 20°C is 320 psig (pounds per square inch gauge). ISPAN SF6 purity: sulfur hexafluoride 99.99% (minimum), air 100 ppm (maximum), carbon tetrafluoride 100 ppm (maximum), and hydrogen fluoride 0.3 ppm (maximum). FDA UDI

Identifiers

Catalog Number
TR9088 FDA UDI
Primary DI / UDI-DI
10860113000116 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 SF6 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.

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 098cdf8d-0159-4a4c-b630-afd0d715ea88 36 fields · synced May 30, 2026