FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956596344
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN36ENMHD
Catalog number
SEN36ENMHD
Device description
SMH ENT PACK
Published
2026-10-29
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
50198956596342PackageGS12In Commercial Distribution
10198956596344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659634250198956596342
1019895659634410198956596344

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
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29
10198956504745CARDINAL HEALTHSCV3MLVCVBSCV3MLVCVB2026-10-29
10198956513310CARDINAL HEALTHSOP23SACACSOP23SACAC2026-10-29
10198956517240CARDINAL HEALTHSOP31KAOSXSOP31KAOSX2026-10-29
10198956521032CARDINAL HEALTHSENCGTACPCSENCGTACPC2026-10-29
10198956531932CARDINAL HEALTHSBA8CBPSPBSBA8CBPSPB2026-10-29
10198956533592CARDINAL HEALTHSAN42PMTMPSAN42PMTMP2026-10-29
10198956533653CARDINAL HEALTHSCV4AAAJHVSCV4AAAJHV2026-10-29
10198956534490CARDINAL HEALTHPU13CPAJEPU13CPAJE2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956521032CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956537484CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956554313CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956583870CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956619944CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-29
10198956577107CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-26
10198956611719CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-26
10198956585058CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956590830CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956595798CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956597082CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
10198956607477CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-23
B098AMS199620Aligned Medical SolutionsAligned Medical SolutionsOGR2026-10-23
10198956548862CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956551961CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956561885CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956562943CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956567610CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956584006CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956598454CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956601338CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956602397CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956602632CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956604117CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956604865CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956605435CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956609853CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956611146CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-19
10198956592483CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-15
10198956604421CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-15