FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956562233
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE4AEEJH8
Catalog number
SNE4AEEJH8
Device description
ENDOSCPIC ENDONASAL SPLMNT PK
Published
2026-08-26
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
50198956562231PackageGS12In Commercial Distribution
10198956562233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895656223150198956562231
1019895656223310198956562233

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 Temperature00

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
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
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
10809160527948HALYARDAVID MEDICAL, INC.OGR2026-07-28