FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439867808
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN23HNCM6
Catalog number
SEN23HNCM6
Device description
MAJOR H AND N PACK
Published
2020-07-27
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
50888439867808PackageGS12In Commercial Distribution
10888439867800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843986780850888439867808
1088843986780010888439867800

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.

Sterilization Methods#

Method table
Method

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106983577CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956362932CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956386150CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956390430CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956402683CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956489424CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956495203CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956501676CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956503809CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956385795CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956423930CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956439269CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956444379CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956466272CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956472907CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956473201CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956487024CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492004CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492585CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492790CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956498587CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956498792CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956500563CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
B098AMS177290Aligned Medical SolutionsAligned Medical SolutionsOGR2026-06-05
10198956443570CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956479609CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956490857CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956492653CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956494237CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956497009CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03