ISPAN

GUDID 00380657971022

ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.

Alcon Laboratories, Inc.

Vitreous/aqueous humour replacement medium, intraoperative

• Primary Device ID: 00380657971022
• NIH Device Record Key: ed981e3f-95a7-411f-b324-ad55b57db42c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISPAN
• Version Model Number: 8065797102
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com

Device Dimensions

• Weight: 125 Gram
• Weight: 125 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380657971022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P900066

FDA Product Code

• LPO: Gases Used Within Eye To Place Pressure On Detached Retina

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [ISPAN]

• 00380657971053: ISPAN C3F8 CONSTELLATION 125GM
• 00380657971046: TANK C3F8 CONSTELLATION LD4
• 00380657971039: ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Pro
• 00380657971022: ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Pro
• 00380657971015: ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Pro
• 00380657970056: ISPAN SF6 CONSTELLATION 125GM
• 00380657970049: TANK SF6 CONSTELLATION LD5
• 00380657970032: ISPAN SF6 SULPHUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto P
• 00380657970025: ISPAN SF6 SULFUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto Pr
• 00380657970018: ISPAN SF6 SULFUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto Pr
• 00380657973033: ISPAN Medical Regulator