FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956514874
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOPOCTKSBB
Catalog number
SOPOCTKSBB
Device description
TOTAL KNEE CUSTOM PACK
Published
2026-10-19
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
50198956514872PackageGS11In Commercial Distribution
10198956514874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895651487250198956514872
1019895651487410198956514874

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
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19
10198956519527CARDINAL HEALTH17-7678I17-7678I2026-10-19
10198956519756CARDINAL HEALTHPO33UEVWBPO33UEVWB2026-10-19
10198956533622CARDINAL HEALTHSOPMIATBSKSOPMIATBSK2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956400795CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956464988CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956506732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956519756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956533622CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956535459CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956535688CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956548305CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956548695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956549722CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956549975CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956550780CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956550902CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956551374CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956557741CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956561984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956565937CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956567894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956568488CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956571242CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956580084CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956581357CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956582354CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956583955CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956584730CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956584938CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956586314CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956588172CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956591301CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956591431CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19