FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956570832
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY1DCPL11
Catalog number
SEY1DCPL11
Device description
CATARACT PACK
Published
2026-09-04
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
50198956570830PackageGS13In Commercial Distribution
10198956570832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657083050198956570830
1019895657083210198956570832

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956561489CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956561588CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956562882CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563124CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563391CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563667CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956566897CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956567191CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956568617CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956569096CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956569218CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570368CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570443CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570542CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10809160532874HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532904HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532959HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532003HalyardAVID MEDICAL, INC.OJK2026-08-27
10809160532102HalyardAVID MEDICAL, INC.OJK2026-08-27
10198956417533CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956478947CARDINAL 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