FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594897772
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP53HPSS6
Catalog number
SOP53HPSS6
Device description
HAND PACK
Published
2022-10-19
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
50195594897770PackageGS14In Commercial Distribution
10195594897772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559489777050195594897770
1019559489777210195594897772

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
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

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
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