Duns Number:879144426
Device Description: ISPAN Sulfur Hexafluoride (SF6) is a liquified gas under pressure and is administered by i 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).
Catalog Number
TR9088
Brand Name
ISPAN SF6 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
-
Product Code
LPO
Product Code Name
Gases Used Within Eye To Place Pressure On Detached Retina
Public Device Record Key
098cdf8d-0159-4a4c-b630-afd0d715ea88
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 05, 2014
Package DI Number
20860113000113
Quantity per Package
6
Contains DI Package
10860113000116
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 |