FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439456325
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP53MXOC2
Catalog number
SOP53MXOC2
Device description
MAJOR EXTREMITY PACK
Published
2019-04-12
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
50888439456323PackageGS16In Commercial Distribution
10888439456325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843945632350888439456323
1088843945632510888439456325

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 Temperature15 Degrees Celsius30 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
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
10198956446045CARDINAL 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