FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956568082
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY48OMIWB
Catalog number
SEY48OMIWB
Device description
OCULOPLASTIC MINORPROCEDURE PK
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
50198956568080PackageGS13In Commercial Distribution
10198956568082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895656808050198956568080
1019895656808210198956568082

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
10198956077348CARDINAL HEALTHSCV57RAKPQSCV57RAKPQ2026-10-12
10198956137547CARDINAL HEALTHPV35VKMBCPV35VKMBC2026-10-12
10198956194632CARDINAL HEALTHSAN33MPMPCSAN33MPMPC2026-10-12
10198956276437CARDINAL HEALTHSOPCNBERVBSOPCNBERVB2026-10-12
10198956301719CARDINAL HEALTHSOP53PKBSCSOP53PKBSC2026-10-12
10198956331259CARDINAL HEALTH32-1024F32-1024F2026-10-12
10198956333611CARDINAL HEALTHPOCGHNWTGPOCGHNWTG2026-10-12
10198956352230CARDINAL HEALTHSAN40SLRWBSAN40SLRWB2026-10-12
10198956361041CARDINAL HEALTHSOP44SPKSCSOP44SPKSC2026-10-12
10198956384439CARDINAL HEALTHSOP32LSISFSOP32LSISF2026-10-12
10198956388376CARDINAL HEALTHSOPCGTHOMESOPCGTHOME2026-10-12
10198956391239CARDINAL HEALTHSOT12CYMOCSOT12CYMOC2026-10-12
10198956399051CARDINAL HEALTHSUT44BPSCBSUT44BPSCB2026-10-12
10198956421240CARDINAL HEALTHSEY23CTRCPSEY23CTRCP2026-10-12
10198956460393CARDINAL HEALTHSEN30EEPRBSEN30EEPRB2026-10-12
10198956463875CARDINAL HEALTH02-0891H02-0891H2026-10-12
10198956471887CARDINAL HEALTHSCV54VCWMUSCV54VCWMU2026-10-12
10198956491298CARDINAL HEALTH31-1019F31-1019F2026-10-12
10198956493803CARDINAL HEALTHSNE11CR83GSNE11CR83G2026-10-12
10198956507425CARDINAL HEALTHSBA42BPSMBSBA42BPSMB2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956573505CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956579736CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956583887CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956586734CARDINAL 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
10198956565326CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25