FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956582118
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN53ESAC3
Catalog number
SEN53ESAC3
Device description
ENT SINUS PACK
Published
2026-09-30
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
50198956582116PackageGS13In Commercial Distribution
10198956582118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658211650198956582116
1019895658211810198956582118

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956549180CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-30
10198956567450CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-30
10198956567740CARDINAL 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
10198956583504CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956587465CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956588967CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10809160538920HALYARDAVID MEDICAL, INC.OGR2026-09-24
10198956350434CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956552272CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956566781CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956566798CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956568631CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956579699CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956582286CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956582989CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956584068CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956584648CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956585379CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22