FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106530399
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY3WEYJA8
Catalog number
SEY3WEYJA8
Device description
EYE PACK
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50197106530397PackageGS112In Commercial Distribution
10197106530399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710653039750197106530397
1019710653039910197106530399

GMDN Terms#

Term, Definition table
TermDefinition
Hygiene apron, single-useA non-sterile garment designed to be worn by healthcare staff for general protection from soiling or spills on the ventral (front) aspect of the body, and typically to prevent penetration of infectious material, during the course of work or a procedure. It is typically made of a thin plastic polymer. This is a single-use garment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS192180Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-19
10198956382930CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956390546CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956516335CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956519626CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956529441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956530584CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
B098AMS193400Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-12
10198956339132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956391949CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956394247CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956414532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956423213CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956513464CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956521520CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956526006CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956526914CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956527362CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956527454CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956528475CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956525733CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525801CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525900CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525917CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525931CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956525955CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956526051CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956526532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
10198956527485CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-06
B098AMS193380Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-05