FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956544086
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PO08KEPCC
Catalog number
PO08KEPCC
Device description
KIT, EXTREMITY PMH
Published
2026-10-12
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
50198956544084PackageGS11In Commercial Distribution
10198956544086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895654408450198956544084
1019895654408610198956544086

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
10198956077348CARDINAL HEALTHSCV57RAKPQSCV57RAKPQ2026-10-12
10198956137547CARDINAL HEALTHPV35VKMBCPV35VKMBC2026-10-12
10198956194632CARDINAL HEALTHSAN33MPMPCSAN33MPMPC2026-10-12
10198956276437CARDINAL HEALTHSOPCNBERVBSOPCNBERVB2026-10-12
10198956301719CARDINAL HEALTHSOP53PKBSCSOP53PKBSC2026-10-12
10198956331259CARDINAL HEALTH32-1024F32-1024F2026-10-12
10198956333611CARDINAL HEALTHPOCGHNWTGPOCGHNWTG2026-10-12
10198956352230CARDINAL HEALTHSAN40SLRWBSAN40SLRWB2026-10-12
10198956361041CARDINAL HEALTHSOP44SPKSCSOP44SPKSC2026-10-12
10198956384439CARDINAL HEALTHSOP32LSISFSOP32LSISF2026-10-12
10198956388376CARDINAL HEALTHSOPCGTHOMESOPCGTHOME2026-10-12
10198956391239CARDINAL HEALTHSOT12CYMOCSOT12CYMOC2026-10-12
10198956399051CARDINAL HEALTHSUT44BPSCBSUT44BPSCB2026-10-12
10198956421240CARDINAL HEALTHSEY23CTRCPSEY23CTRCP2026-10-12
10198956460393CARDINAL HEALTHSEN30EEPRBSEN30EEPRB2026-10-12
10198956463875CARDINAL HEALTH02-0891H02-0891H2026-10-12
10198956471887CARDINAL HEALTHSCV54VCWMUSCV54VCWMU2026-10-12
10198956491298CARDINAL HEALTH31-1019F31-1019F2026-10-12
10198956493803CARDINAL HEALTHSNE11CR83GSNE11CR83G2026-10-12
10198956507425CARDINAL HEALTHSBA42BPSMBSBA42BPSMB2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956276437CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956301719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956333611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956361041CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956384439CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956388376CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956519541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956530782CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956540958CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956550063CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956552104CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956552531CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956556478CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956556591CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956557079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956564145CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567405CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567672CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567931CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956569294CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956570061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956570078CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956573567CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956574571CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956575585CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956577275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956578197CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956580367CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956581142CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956581340CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12