FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106854075
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP21KEA11
Catalog number
SOP21KEA11
Device description
ATHENS TOTAL KNEE PK
Published
2024-12-13
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106854073PackageGS11In Commercial Distribution
10197106854075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710685407350197106854073
1019710685407510197106854075

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain 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
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
10198956232792CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956334342CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956359611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956364837CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956368002CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956392755CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956408401CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956439726CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956442450CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448483CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956458291CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956461512CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956475328CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956481367CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956484269CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956487314CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956489875CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504424CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504776CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505490CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505704CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956506909CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956507685CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508019CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508170CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509382CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956510418CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16