FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956417229
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY45CPPSE
Catalog number
SEY45CPPSE
Device description
CATARACT PACK
Published
2026-06-03
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
50198956417227PackageGS13In Commercial Distribution
10198956417229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895641722750198956417227
1019895641722910198956417229

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
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397682CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956478992CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956487642CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10197106817643CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956351738CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956407084CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956410145CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956418387CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421219CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421257CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956439559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956463523CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956475595CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956486591CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956488724CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956488816CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956489257CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956489738CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956490475CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956494244CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
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10193489421590Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJK2023-06-08
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