FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956446045
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP36TKNHF
Catalog number
SOP36TKNHF
Device description
NWH TOTAL KNEE PACK
Published
2026-06-05
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
OJHOrthopedic tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956446043PackageGS11In Commercial Distribution
10198956446045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895644604350198956446043
1019895644604510198956446045

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286665CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956305274CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956345928CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956359963CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956364905CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956382657CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956393141CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956395275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956404144CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956404656CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956415171CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956422971CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956430716CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956439481CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956440814CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956446038CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956452930CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956453173CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956454453CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956454866CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956458710CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956463912CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956465633CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956471856CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956472792CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956473140CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956475250CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956476004CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956476257CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956477032CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05