FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956590830
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SENWGEPSFA
Catalog number
SENWGEPSFA
Device description
EAR PACK
Published
2026-10-23
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
50198956590838PackageGS12In Commercial Distribution
10198956590830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659083850198956590838
1019895659083010198956590830

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
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
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956585058CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956595798CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956597082CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956607477CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
B098AMS199620Aligned Medical SolutionsAligned Medical SolutionsOGR2026-10-23
10198956548862CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956551961CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956561885CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956562943CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956567610CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956584006CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956598454CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956601338CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956602397CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956602632CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956604117CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956604865CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956605435CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956609853CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956611146CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956592483CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-15
10198956604421CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-15
10198956570740CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-13
10198956599468CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-13
10198956601468CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-13
10198956460393CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956519749CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956547698CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956565340CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956579880CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12