FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594056009
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY41BEUS3
Catalog number
SEY41BEUS3
Device description
BASIC EYE PACK
Published
2021-04-23
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
50195594056009PackageGS16In Commercial Distribution
10195594056001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559405600950195594056009
1019559405600110195594056001

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 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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956604735CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-15
10198956564237CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-13
10198956421240CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956553361CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956562912CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567412CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567634CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956568082CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956573505CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956579736CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956583887CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956586734CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956589032CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956597563CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956604469CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956463530CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956538702CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956561717CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956564541CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956566873CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956589582CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956592780CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10809160539804HalyardAVID MEDICAL, INC.OJK2026-10-05
10198956589117CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-30
10198956595088CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-30
10198956517417CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956541955CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956582330CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956588356CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956592674CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29