Home GUDID 10380657530684 UNIPURE & UNIPEXY
Primary DI 10380657530684
Brand UNIPURE & UNIPEXY
Company Alcon Laboratories, Inc.
Model 8065753068
Catalog number 8065753068
Device description UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Published 2024-10-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LPO Gases Used Within Eye To Place Pressure On Detached Retina
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LPO Gases Used Within Eye To Place Pressure On Detached Retina Ophthalmic 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10380657530684 Package GS1 10 In Commercial Distribution 00380657530687 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10380657530684 10380657530684 00380657530687 00380657530687 380657530687 0380657530687
GMDN Terms# Term, Definition table Term Definition Perfluoropropane refillable cylinder A container designed as a refillable cylinder used to hold compressed medical grade perfluoropropane (C3F8) under safe conditions at high pressure. It is filled with C3F8 when delivered from the gas/device supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote C3F8 content. It is made of steel or aluminium and must be used together with a pressure regulator in order to release the C3F8 at the correct working pressure. C3F8 is used predominately as a tamponade gas to aid the healing process from retinal surgery.
Regulatory Flags# DUNS number 008018525 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00819601025660 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 00819601025677 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 00819601025684 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 00819601025691 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 00819601025707 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 00819601025714 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 10819601025667 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 10819601025674 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 10819601025681 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 10819601025698 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 10819601025704 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 10819601025711 BVI Medical Airgas Therapeutics, LLC LPO 2025-05-20 00380657530663 UNIPURE & UNIFEYE Alcon Laboratories, Inc. LPO 2024-10-28 00380657530670 UNIPURE & UNIFEYE Alcon Laboratories, Inc. LPO 2024-10-28 00380657530687 UNIPURE & UNIPEXY Alcon Laboratories, Inc. LPO 2024-10-28 00380657530694 UNIPURE & UNIPEXY Alcon Laboratories, Inc. LPO 2024-10-28 10380657530660 UNIPURE & UNIFEYE Alcon Laboratories, Inc. LPO 2024-10-28 10380657530677 UNIPURE & UNIFEYE Alcon Laboratories, Inc. LPO 2024-10-28 10380657530691 UNIPURE & UNIPEXY Alcon Laboratories, Inc. LPO 2024-10-28 00885556653371 R3 Smith & Nephew, Inc. LPO 2016-07-19 00885556653388 R3 Smith & Nephew, Inc. LPO 2016-07-19 00885556653395 R3 Smith & Nephew, Inc. LPO 2016-07-19 00885556653401 R3 Smith & Nephew, Inc. LPO 2016-07-19 00885556653418 R3 Smith & Nephew, Inc. LPO 2016-07-19 00885556653425 R3 Smith & Nephew, Inc. LPO 2016-07-19 10860113000109 ISPAN C3F8 Intraocular Gas ESCALON MEDICAL CORP. LPO 2014-11-05 10860113000116 ISPAN SF6 Intraocular Gas ESCALON MEDICAL CORP. LPO 2014-11-05 00380657971046 ISPAN Alcon Laboratories, Inc. LPO 2014-10-07 00380657970018 ISPAN Alcon Laboratories, Inc. LPO 2014-09-24 00380657970025 ISPAN Alcon Laboratories, Inc. LPO 2014-09-24