FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106621042
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP41KPNR3
Catalog number
SOP41KPNR3
Device description
KNEE PACK
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OHAHeart valve, more than minimally manipulated allograft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHAHeart Valve, More Than Minimally Manipulated AllograftUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106621040PackageGS12In Commercial Distribution
10197106621042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710662104050197106621040
1019710662104210197106621042

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956105799CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
10198956108752CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
50198956105797CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
50198956108750CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
10197106815731CARDINAL HEALTHCardinal Health 200, LLCOHA2024-11-01
50197106815739CARDINAL HEALTHCardinal Health 200, LLCOHA2024-11-01
10197106751695CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-25
50197106751693CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-25
10197106769836CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-08
50197106769834CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-08
10197106748787CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-19
50197106748785CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-19
10197106748794CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-11
50197106748792CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-11
10197106687888CARDINAL HEALTHCardinal Health 200, LLCOHA2024-07-03
50197106687886CARDINAL HEALTHCardinal Health 200, LLCOHA2024-07-03
10197106652541CARDINAL HEALTHCardinal Health 200, LLCOHA2024-06-15
50197106652549CARDINAL HEALTHCardinal Health 200, LLCOHA2024-06-15
10197106627860CARDINAL HEALTHCardinal Health 200, LLCOHA2024-05-16
50197106627868CARDINAL HEALTHCardinal Health 200, LLCOHA2024-05-16
10197106638620CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-17
50197106638628CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-17
50197106621040CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-10
10197106589458CARDINAL HEALTHCardinal Health 200, LLCOHA2024-03-28
50197106589456CARDINAL HEALTHCardinal Health 200, LLCOHA2024-03-28
10197106571835CARDINAL HEALTHCardinal Health 200, LLCOHA2024-02-14
50197106571833CARDINAL HEALTHCardinal Health 200, LLCOHA2024-02-14
10197106478479CARDINAL HEALTHCardinal Health 200, LLCOHA2024-01-09
10197106538753CARDINAL HEALTHCardinal Health 200, LLCOHA2024-01-09
10197106504321CARDINAL HEALTHCardinal Health 200, LLCOHA2024-01-08