FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594693082
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY63EYWPG
Catalog number
SEY63EYWPG
Device description
EYE PACK
Published
2022-06-24
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
50195594693082PackageGS15In Commercial Distribution
10195594693084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559469308250195594693082
1019559469308410195594693084

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 Temperature040 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956345645CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956394315CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956442313CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956453838CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956467316CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956470132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956474956CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956484962CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956486522CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956488281CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956488762CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10198956489042CARDINAL HEALTHCardinal Health 200, LLCOJK2026-05-25
10809160521731HalyardAVID MEDICAL, INC.OJK2026-05-22
50198956370645CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956378559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956390698CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416022CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416329CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956416350CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956417296CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956421088CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956421897CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956422177CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956422344CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956426847CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956428261CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956429299CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956429466CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956430998CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-24
50198956330465CARDINAL HEALTHCardinal Health 200, LLCOJK2026-03-23