FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956538771
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY38CPI15
Catalog number
SEY38CPI15
Device description
CATARACT PACK
Published
2026-07-31
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
50198956538779PackageGS16In Commercial Distribution
10198956538771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653877950198956538779
1019895653877110198956538771

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 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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956540750CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540798CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956544567CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10809160528228HalyardAVID MEDICAL, INC.OJK2026-07-31
10809160528235HalyardAVID MEDICAL, INC.OJK2026-07-31
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
10198956470538CARDINAL 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