FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956582859
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN35LEBLW
Catalog number
SEN35LEBLW
Device description
LARYNGOSCOPY ESOPHAGOSCOPY PK
Published
2026-09-21
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
50198956582857PackageGS12In Commercial Distribution
10198956582859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658285750198956582857
1019895658285910198956582859

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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538920HALYARDAVID MEDICAL, INC.OGR2026-09-24
10198956350434CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956552272CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956566781CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956566798CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956568631CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956579699CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956582286CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956582989CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956584068CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956584648CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956585379CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956521285CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956547476CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956547902CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956555945CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956556973CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956558809CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956578418CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956579248CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
B098AMS12206A0Aligned Medical SolutionsAligned Medical SolutionsOGR2026-09-18
10198956463394CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956503397CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956519534CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956535848CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956540804CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956545540CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956546943CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956547605CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956556270CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04