FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106339624
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SENHDMEMJO
Catalog number
SENHDMEMJO
Device description
MAJOR EAR PACK SMJH 184603
Published
2024-02-21
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
50197106339624PackageGS12In Commercial Distribution
10197106339626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710633962450197106339624
1019710633962610197106339626

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.

Storage And Handling#

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

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956382497CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956416086CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956416994CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956463844CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956469389CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956479951CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956480254CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956485464CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956486218CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
10198956486249CARDINAL HEALTHCardinal Health 200, LLCOGR2026-05-25
50198956322897CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-24
50198956376784CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-24
50198956397574CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-24
50198956426779CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-24
50198956324709CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956326352CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956327120CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956355109CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956356687CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956361209CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956362824CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956366815CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956371833CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956374513CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956393033CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956394757CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956401318CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956412741CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956415117CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956415674CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23