FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956154421
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY11LAEE4
Catalog number
SEY11LAEE4
Device description
DIRECT LARYNGOSCOPY PACK
Published
2025-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50198956154429PackageGS15In Commercial Distribution
10198956154421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895615442950198956154429
1019895615442110198956154421

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
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
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