FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956402416
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP13OHEXE
Catalog number
SOP13OHEXE
Device description
ORIF HIP PACK
Published
2026-10-06
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
50198956402414PackageGS12In Commercial Distribution
10198956402416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895640241450198956402414
1019895640241610198956402416

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
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06
10198956439702CARDINAL HEALTHSOP23ARARQSOP23ARARQ2026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286672CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956301511CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956306059CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956354494CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956379824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956439702CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956470163CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956512146CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956514522CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956519985CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956523555CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956532083CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956543089CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956543942CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956545359CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548855CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548916CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548961CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956552012CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956552098CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956554696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956556102CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956556690CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956560796CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956562721CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956567399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956567696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956568129CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956568747CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956569447CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06