FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594135928
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN23TOXF1
Catalog number
SEN23TOXF1
Device description
TONSIL PACK
Published
2021-06-10
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
OFACardiovascular surgical instruments tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFACardiovascular Surgical Instruments TrayCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594135926PackageGS15In Commercial Distribution
10195594135928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559413592650195594135926
1019559413592810195594135928

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. 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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106720967CARDINAL HEALTHCardinal Health 200, LLCOFA2024-11-15
50197106720965CARDINAL HEALTHCardinal Health 200, LLCOFA2024-11-15
10197106636435CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
50197106636433CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
10197106457368CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
10809160413616Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
50197106457366CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
20809160413613Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
10197106458495CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
50197106458493CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
00851788001174On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001730On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001747On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001006On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-08
10197106140499CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
50197106140497CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
10195594468828CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
50195594468826CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
10809160360156Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
20809160360153Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
00749756714402DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
50749756714407DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
50195594135926CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
10809160284223Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
20809160284220Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
00811870033568CUSTOM HEALTHCARE SYSTEMS, INC.Manus Medical, LLCOFA2019-07-29
20811870033562CUSTOM HEALTHCARE SYSTEMS, INC.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-07-29
00811870032264Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24
00811870032677Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24
00811870033377Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24