FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956594654
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN13EABT2
Catalog number
SEN13EABT2
Device description
ESOPHAGEAL ATRESIA PACK
Published
2026-10-06
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
50198956594652PackageGS12In Commercial Distribution
10198956594654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659465250198956594652
1019895659465410198956594654

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
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956402416CARDINAL HEALTHSOP13OHEXESOP13OHEXE2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956439535CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956554122CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956564305CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956568679CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956580374CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956583078CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956589834CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956593671CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956594449CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956596689CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956598195CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956598768CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956599284CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956600492CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956549180CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-30
10198956567450CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-30
10198956567740CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-30
10198956582118CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-30
10198956593619CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-30
10198956593916CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-30
10198956143401CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-29
10198956513594CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-29
10198956544093CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-29
10198956553897CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-29
10198956565524CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-29
10198956588608CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-29
10198956592506CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-29
10198956541757CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956550568CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956562615CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25