FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439385083
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN5BEASMH
Catalog number
SEN5BEASMH
Device description
PACK EAR
Published
2019-02-19
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
50888439385081PackageGS14In Commercial Distribution
10888439385083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843938508150888439385081
1088843938508310888439385083

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956391888CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01
10198956392427CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01
10198956444003CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01
10198956460416CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01
10198956475724CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01
10198956476455CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01
10198956487796CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01
10198956490505CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01
10198956492318CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-01