FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956468153
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN13TANAO
Catalog number
SEN13TANAO
Device description
T AND A PACK
Published
2026-07-06
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
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956468151PackageGS15In Commercial Distribution
10198956468153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895646815150198956468151
1019895646815310198956468153

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.

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
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
10198956358942CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956389007CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956457157CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956515833CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956526556CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956527164CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956527638CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10197106983577CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956362932CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956386150CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956390430CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956402683CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956489424CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956495203CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956501676CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956503809CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956385795CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956423930CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956439269CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956444379CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956466272CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956472907CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956473201CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956487024CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492004CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492585CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492790CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956498587CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956498792CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956500563CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05