FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594339843
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN43TNTSQ
Catalog number
SEN43TNTSQ
Device description
T AND A PACK
Published
2021-10-27
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
50195594339843PackageGS15In Commercial Distribution
10195594339845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559433984350195594339843
1019559433984510195594339845

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.

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

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