FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956472945
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP29TIWCL
Catalog number
SOP29TIWCL
Device description
TOTAL HIP PACK
Published
2026-08-17
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
50198956472943PackageGS12In Commercial Distribution
10198956472945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895647294350198956472943
1019895647294510198956472945

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
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956506046CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956513402CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956521223CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956530140CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956530317CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956530324CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956535626CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956549029CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956554245CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956555198CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956555204CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956556737CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10197106959497CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956377691CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956442399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956442436CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956513938CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956517264CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956520844CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956522961CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956534827CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956534841CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956534889CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956539846CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956541665CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956542433CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956545526CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956553613CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956555969CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10809160530078HALYARDAVID MEDICAL, INC.OJH2026-08-17