FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106800720
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY32EYMB4
Catalog number
SEY32EYMB4
Device description
EYE PACK NORTHWOODS
Published
2024-10-15
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
50197106800728PackageGS18In Commercial Distribution
10197106800720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710680072850197106800728
1019710680072010197106800720

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

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956414884CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956416222CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956529076CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956534230CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956536661CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956538016CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956538771CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540750CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540798CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956544567CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10809160528228HalyardAVID MEDICAL, INC.OJK2026-07-31
10809160528235HalyardAVID MEDICAL, INC.OJK2026-07-31
10809160528143HalyardAVID MEDICAL, INC.OJK2026-07-30
10809160528082HalyardAVID MEDICAL, INC.OJK2026-07-29
10809160528105HalyardAVID MEDICAL, INC.OJK2026-07-29
10198956409712CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956414471CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956414501CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956470538CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956480490CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956520431CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956523722CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956528581CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956528628CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956529199CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956531994CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956533363CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956533448CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534117CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534124CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27