FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956514584
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN4EHNHTD
Catalog number
SEN4EHNHTD
Device description
HMT HEAD AND NECK PACK
Published
2026-07-20
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
50198956514582PackageGS12In Commercial Distribution
10198956514584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895651458250198956514582
1019895651458410198956514584

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, medicatedA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform an ENT surgical procedure. 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
50885380213234Kendall3320533205B2026-10-28
50885380213241Kendall3320633206B2026-10-28
50885380213258Kendall3320733207B2026-10-28
10885380169922CARDINAL HEALTH212WPR212WPR2020-01-13
20884521100449Monoject8611U8611U2016-09-24
20884521100456Monoject8612U8612U2016-09-24
20192253024668Monoject888120201888812020182026-07-15
10192253040203Argyle1604091604092025-01-08
10192253040210Argyle43201432012025-01-08
10192253040241Argyle43308433082025-01-08
10192253040258Argyle43309433092025-01-08
10192253040265Argyle43311433112025-01-08
10192253040289Argyle888816011988881601192025-01-08
10192253040326Argyle888816040888881604082025-01-08
10192253040333Argyle888816042488881604242025-01-08
10192253040340Argyle888816043288881604322025-01-08
10192253040395Argyle888816083888881608382025-01-08
10192253040401Argyle888816085388881608532025-01-08
10192253046656Kendall55566BAMD55566BAMD2023-10-09
10195594567743CARDINAL HEALTHSBACNUBOL3SBACNUBOL32022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956577107CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-26
10198956611719CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-26
10198956585058CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956590830CARDINAL 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