AccessGUDID - DEVICE: ISPAN SF6 Intraocular Gas (10860113000116)

GUDID

Device Identifier (DI) Information

Brand Name: ISPAN SF6 Intraocular Gas
Version or Model: 20 g Cylinder
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TR9088
Company Name: ESCALON MEDICAL CORP.

Primary DI Number: 10860113000116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 879144426 *Terms of Use

Device 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).

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35907	Vitreous/aqueous humour replacement medium, intraoperative	A nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during the intervention, preserve tissue integrity, protect from surgical trauma, and/or to function as a tamponade during retinal reattachment). It may be supplied in a prefilled sterile syringe or other container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPO	Gases Used Within Eye To Place Pressure On Detached Retina

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Contents under pressure. Do not puncture. Do not store or use near heat or open flame. Use with pressure reducing gas regulator in an upright position.
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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