FDA.reportPublic FDA data

UNIPURE & UNIPEXY

Primary DI
00380657530687
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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPOGases Used Within Eye To Place Pressure On Detached Retina

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPOGases Used Within Eye To Place Pressure On Detached RetinaOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380657530684PackageGS110In Commercial Distribution
00380657530687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065753068410380657530684
00380657530687003806575306873806575306870380657530687

GMDN Terms#

Term, Definition table
TermDefinition
Perfluoropropane refillable cylinderA 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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819601025660BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025677BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025684BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025691BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025707BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025714BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025667BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025674BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025681BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025698BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025704BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025711BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00380657530663UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
00380657530670UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
00380657530694UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
10380657530660UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
10380657530677UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
10380657530684UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
10380657530691UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
00885556653371R3Smith & Nephew, Inc.LPO2016-07-19
00885556653388R3Smith & Nephew, Inc.LPO2016-07-19
00885556653395R3Smith & Nephew, Inc.LPO2016-07-19
00885556653401R3Smith & Nephew, Inc.LPO2016-07-19
00885556653418R3Smith & Nephew, Inc.LPO2016-07-19
00885556653425R3Smith & Nephew, Inc.LPO2016-07-19
10860113000109ISPAN C3F8 Intraocular GasESCALON MEDICAL CORP.LPO2014-11-05
10860113000116ISPAN SF6 Intraocular GasESCALON MEDICAL CORP.LPO2014-11-05
00380657971046ISPANAlcon Laboratories, Inc.LPO2014-10-07
00380657970018ISPANAlcon Laboratories, Inc.LPO2014-09-24
00380657970025ISPANAlcon Laboratories, Inc.LPO2014-09-24