FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956593176
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP53ATMBO
Catalog number
SOP53ATMBO
Device description
ANTERIOR TOTAL HIP PACK
Published
2026-10-23
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
50198956593174PackageGS12In Commercial Distribution
10198956593176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659317450198956593174
1019895659317610198956593176

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 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
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956201606CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956487918CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956505766CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956508682CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956553552CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956572140CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956572171CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956572270CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956574427CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956581111CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956581791CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956584723CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956585829CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956585843CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956586598CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956594807CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956595095CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956595163CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956596863CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956598829CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956606036CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956606593CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956608573CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956609297CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956609600CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956610453CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956610958CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956611009CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956611481CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956612105CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23