FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956478947
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY11CAUHM
Catalog number
SEY11CAUHM
Device description
CATARACT PACK
Published
2026-08-26
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
50198956478945PackageGS14In Commercial Distribution
10198956478947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895647894550198956478945
1019895647894710198956478947

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.

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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160532003HalyardAVID MEDICAL, INC.OJK2026-08-27
10809160532102HalyardAVID MEDICAL, INC.OJK2026-08-27
10198956417533CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956503069CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956556539CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956561236CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956563360CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956565135CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10809160531839HalyardAVID MEDICAL, INC.OJK2026-08-26
B098AMS17526A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-08-23
10809160530733HalyardAVID MEDICAL, INC.OJK2026-08-19
10198956555129CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-18
10198956475090CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956510579CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956542624CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956544475CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956544543CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956545281CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956546462CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956548749CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956554559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-17
10198956414884CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956416222CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956529076CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956534230CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956536661CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956538016CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956538771CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540750CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540798CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31