FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106266304
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN18EPA13
Catalog number
SEN18EPA13
Device description
EAR PACK
Published
2023-05-08
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
50197106266302PackageGS12In Commercial Distribution
10197106266304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710626630250197106266302
1019710626630410197106266304

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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956409767CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956502697CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956548336CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956551725CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956557703CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956562134CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956562233CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956563803CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956564565CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956463738CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-18
10198956416598CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956501799CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956547445CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956547766CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956552135CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956553224CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956553316CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
B098AMS188850Aligned Medical SolutionsAligned Medical SolutionsOGR2026-08-17
B098AMS188840Aligned Medical SolutionsAligned Medical SolutionsOGR2026-08-16
10198956524064CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956531321CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956532885CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956534025CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956534360CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956537859CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956538665CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956540781CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956541238CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956541412CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956542464CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31