FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439465327
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY54CAGRT
Catalog number
SEY54CAGRT
Device description
CATARACT PACK
Published
2019-06-04
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439465325PackageGS16In Commercial Distribution
10888439465327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843946532550888439465325
1088843946532710888439465327

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, medicated, single-useA collection of various sterile ophthalmic surgical instruments, dressings, and the necessary materials which includes a pharmaceutical(s) intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
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
10192253033502Monoject118030055511803005552022-10-21
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10630140031403CONVERTORS29461294612016-06-28
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10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397682CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956417229CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956478992CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956487642CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10197106817643CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956351738CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956407084CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956410145CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956418387CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421219CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421257CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956439559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956463523CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956475595CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956486591CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956488724CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956488816CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956489257CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956489738CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956490475CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956494244CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10809160522318HalyardAVID MEDICAL, INC.OJK2026-06-01
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10193489421590Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489422702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08