FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106863633
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN43SIGU6
Catalog number
SEN43SIGU6
Device description
SINUS PACK
Published
2024-12-09
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
50197106863631PackageGS16In Commercial Distribution
10197106863633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710686363150197106863631
1019710686363310197106863633

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956218536CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956364523CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956367326CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956396180CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956435858CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443761CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443815CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443839CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956503243CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956503403CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956505421CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956505698CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956506671CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956508200CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956513440CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514034CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514072CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514584CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956516557CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956520189CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956523012CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956525689CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956526426CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956528031CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956528703CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956529267CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530454CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530539CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530553CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956531352CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20