FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956586734
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY33ORSFL
Catalog number
SEY33ORSFL
Device description
OR EYE PACK
Published
2026-10-12
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
50198956586732PackageGS12In Commercial Distribution
10198956586734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658673250198956586732
1019895658673410198956586734

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.

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
10198956537798CARDINAL HEALTHSOP53TOWRGSOP53TOWRG2026-10-13
10198956539914CARDINAL HEALTHSOP48EX85ASOP48EX85A2026-10-13
10198956541658CARDINAL HEALTHSAN1DRPUNCSAN1DRPUNC2026-10-13
10198956545182CARDINAL HEALTHSOP53SLVLLSOP53SLVLL2026-10-13
10198956549050CARDINAL HEALTHSOP45THBMJSOP45THBMJ2026-10-13
10198956559516CARDINAL HEALTH08-0857C08-0857C2026-10-13
10198956562950CARDINAL HEALTHSBA43MPMADSBA43MPMAD2026-10-13
10198956563223CARDINAL HEALTHSOP42ARBTHSOP42ARBTH2026-10-13
10198956564237CARDINAL HEALTHSEY45BPPAESEY45BPPAE2026-10-13
10198956570740CARDINAL HEALTHSEN48ESSNASEN48ESSNA2026-10-13
10198956570993CARDINAL HEALTH34-2403F34-2403F2026-10-13
10198956573024CARDINAL HEALTHSMA54MGFMPSMA54MGFMP2026-10-13
10198956577084CARDINAL HEALTH08-0857D08-0857D2026-10-13
10198956578753CARDINAL HEALTH34-7753A34-7753A2026-10-13
10198956588721CARDINAL HEALTHSMA40DERWDSMA40DERWD2026-10-13
10198956589810CARDINAL HEALTHSBAOCRPS30SBAOCRPS302026-10-13
10198956592698CARDINAL HEALTHSAN53ANOV6SAN53ANOV62026-10-13
10198956593770CARDINAL HEALTHSOTOCURGR3SOTOCURGR32026-10-13
10198956595071CARDINAL HEALTH31-826AW31-826AW2026-10-13
10198956597891CARDINAL HEALTHSBA43RPUSESBA43RPUSE2026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956564237CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-13
10198956421240CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956553361CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956562912CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567412CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567634CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956568082CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956573505CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956579736CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956583887CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956589032CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956597563CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956604469CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956463530CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956538702CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956561717CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956564541CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956566873CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956589582CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956592780CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10809160539804HalyardAVID MEDICAL, INC.OJK2026-10-05
10198956589117CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-30
10198956595088CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-30
10198956517417CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956541955CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956582330CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956588356CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956592674CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10809160539330HALYARDAVID MEDICAL, INC.OJK2026-09-29
10198956538795CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25