FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106638620
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOPHFEXP13
Catalog number
SOPHFEXP13
Device description
EXTREMITY PACK
Published
2024-04-17
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
50197106638628PackageGS13In Commercial Distribution
10197106638620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710663862850197106638628
1019710663862010197106638620

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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
50197106638628CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-17
10197106621042CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-10
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