FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106974513
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEYOCEPVH8
Catalog number
SEYOCEPVH8
Device description
EYE PACK
Published
2025-03-11
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
50197106974511PackageGS14In Commercial Distribution
10197106974513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710697451150197106974511
1019710697451310197106974513

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS131930Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
B098AMS14577A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
10198956363960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956385535CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956417434CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956418622CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956484986CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956489882CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956498495CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956518513CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956526013CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956529069CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956531222CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956532175CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956532694CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956533820CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956533981CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
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