Duns Number:879144426
Device Description: ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administered by inj 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).
Catalog Number
TR9089
Brand Name
ISPAN C3F8 Intraocular Gas
Version/Model Number
20 g Cylinder
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P900066,P900066,P900066
Product Code
LPO
Product Code Name
Gases Used Within Eye To Place Pressure On Detached Retina
Public Device Record Key
bbdcf80e-2408-45b9-abfa-987041c4fa25
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 05, 2014
Package DI Number
20860113000106
Quantity per Package
6
Contains DI Package
10860113000109
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |