FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106607426
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PO23THNLB
Catalog number
PO23THNLB
Device description
KIT, TOTAL HIP NH ORTHO
Published
2024-06-18
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
50197106607426PackageGS12In Commercial Distribution
10197106607428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710660742650197106607426
1019710660742810197106607428

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10198956527737CARDINAL HEALTHSEN52IPLL2SEN52IPLL22026-07-09
10198956527744CARDINAL HEALTHSANHDLPV29SANHDLPV292026-07-09
10198956527799CARDINAL HEALTHSMA69DCMV5SMA69DCMV52026-07-09
10198956527805CARDINAL HEALTHPV11OP342PV11OP3422026-07-09
10198956527829CARDINAL HEALTHSBA73TFK18SBA73TFK182026-07-09
10198956527843CARDINAL HEALTHSOPHDODL29SOPHDODL292026-07-09
10198956527850CARDINAL HEALTHPVX4EVP10PVX4EVP102026-07-09
10198956527867CARDINAL HEALTHPV33AMMY2PV33AMMY22026-07-09
10198956527874CARDINAL HEALTHSBA57LKO31SBA57LKO312026-07-09
10198956527904CARDINAL HEALTHSOP81OPAB4SOP81OPAB42026-07-09
10198956527959CARDINAL HEALTHSAN34BAB26SAN34BAB262026-07-09
10198956527980CARDINAL HEALTHSAN25NMC10SAN25NMC102026-07-09
10198956528017CARDINAL HEALTHPV23OHN11PV23OHN112026-07-09
10198956528048CARDINAL HEALTHPV29VAMM3PV29VAMM32026-07-09
10198956528079CARDINAL HEALTHSBA45RLIM1SBA45RLIM12026-07-09
10198956528086CARDINAL HEALTHSAN16APS34SAN16APS342026-07-09
10198956528109CARDINAL HEALTHPVOCOH159PVOCOH1592026-07-09
10198956528116CARDINAL HEALTHSMAOCCSMB1SMAOCCSMB12026-07-09
10198956528185CARDINAL HEALTHSNE57SP024SNE57SP0242026-07-09
10198956528208CARDINAL HEALTHSAN3BCCK19SAN3BCCK192026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956527843CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956527904CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956528413CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
00840124526037FuzeFix MiniFUSION ORTHOPEDICS, LLCOJH2026-07-07
05060267134547FORCECORDXIROS LTDOJH2026-07-06
10198956182004CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956373068CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956407053CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956414693CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956428881CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956429901CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956457775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956474895CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956481015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956484177CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956490833CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956491038CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956492158CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956492196CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956494572CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956494695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956497498CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956498426CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956498471CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956499775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956503199CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956503298CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956508798CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956509368CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06
10198956512962CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-06