FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106891139
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEYCGRTA40
Catalog number
SEYCGRTA40
Device description
RETINAL PACK
Published
2025-01-15
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
CodeName
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106891139PackageGS12In Commercial Distribution
10197106891131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710689113950197106891139
1019710689113110197106891131

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
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
10193489212310Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489217391Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489413038Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489417180Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489419375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489419382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489421590Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
10193489422702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08