FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956470538
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY56BSPCY
Catalog number
SEY56BSPCY
Device description
PACK EYE PCH
Published
2026-07-27
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
50198956470536PackageGS12In Commercial Distribution
10198956470538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895647053650198956470536
1019895647053810198956470538

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 Temperature00

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528143HalyardAVID MEDICAL, INC.OJK2026-07-30
10809160528082HalyardAVID MEDICAL, INC.OJK2026-07-29
10809160528105HalyardAVID MEDICAL, INC.OJK2026-07-29
10198956409712CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956414471CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956414501CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956480490CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956520431CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956523722CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956528581CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956528628CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956529199CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956531994CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956533363CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956533448CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534117CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534124CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534759CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534902CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956537873CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956538542CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956541153CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956541221CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
B098AMS131940Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-26
B098AMS131950Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-26
B098AMS131960Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-25
B098AMS131930Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
B098AMS14577A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
10198956363960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956385535CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20