FDA.reportPublic FDA data

UNIPURE & UNIFEYE

Primary DI
00380657530670
Brand
UNIPURE & UNIFEYE
Company
Alcon Laboratories, Inc.
Model
8065753067
Catalog number
8065753067
Device description
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE 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
10380657530677PackageGS16In Commercial Distribution
00380657530670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065753067710380657530677
00380657530670003806575306703806575306700380657530670

GMDN Terms#

Term, Definition table
TermDefinition
Sulfur hexafluoride refillable cylinderA container designed as a refillable cylinder used to hold compressed medical grade sulphur hexafluoride (SF6) under safe conditions at high pressure. It is typically filled with SF6 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 SF6 content. The cylinder is typically made of steel and must be used together with a pressure regulator in order to release the SF6 at the correct working pressure. SF6 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
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
00380658552060Clareon TruPlusREYWT8REYWT8.2802026-05-14
00380658552077Clareon TruPlusREYWT8REYWT8.2852026-05-14
00380658552084Clareon TruPlusREYWT8REYWT8.2902026-05-14
00380658552091Clareon TruPlusREYWT8REYWT8.2952026-05-14
00380658552107Clareon TruPlusREYWT8REYWT8.3002026-05-14
00380658552114Clareon TruPlusREYWT8REYWT8.3102026-05-14
00380658552121Clareon TruPlusREYWT8REYWT8.3202026-05-14
00380658552138Clareon TruPlusREYWT8REYWT8.3302026-05-14
00380658552145Clareon TruPlusREYWT8REYWT8.3402026-05-14
00380658552152Clareon TruPlusREYWT9REYWT9.0602026-05-14
00380658552169Clareon TruPlusREYWT9REYWT9.0652026-05-14
00380658552176Clareon TruPlusREYWT9REYWT9.0702026-05-14

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
00380657530687UNIPURE & UNIPEXYAlcon 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