FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956553316
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PEMHETB21
Catalog number
PEMHETB21
Device description
KIT,MAJOR ENT,HERMANN
Published
2026-08-17
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
50198956553314PackageGS11In Commercial Distribution
10198956553316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895655331450198956553314
1019895655331610198956553316

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
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10197106944028CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956371811CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956395053CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956464636CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956479975CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956483538CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956498754CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956502734CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956509207CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27