FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956602199
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PEV2ATN11
Catalog number
PEV2ATN11
Device description
KIT, ENT T AND A
Published
2026-10-12
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
50198956602197PackageGS12In Commercial Distribution
10198956602199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895660219750198956602197
1019895660219910198956602199

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
10198956077348CARDINAL HEALTHSCV57RAKPQSCV57RAKPQ2026-10-12
10198956137547CARDINAL HEALTHPV35VKMBCPV35VKMBC2026-10-12
10198956194632CARDINAL HEALTHSAN33MPMPCSAN33MPMPC2026-10-12
10198956276437CARDINAL HEALTHSOPCNBERVBSOPCNBERVB2026-10-12
10198956301719CARDINAL HEALTHSOP53PKBSCSOP53PKBSC2026-10-12
10198956331259CARDINAL HEALTH32-1024F32-1024F2026-10-12
10198956333611CARDINAL HEALTHPOCGHNWTGPOCGHNWTG2026-10-12
10198956352230CARDINAL HEALTHSAN40SLRWBSAN40SLRWB2026-10-12
10198956361041CARDINAL HEALTHSOP44SPKSCSOP44SPKSC2026-10-12
10198956384439CARDINAL HEALTHSOP32LSISFSOP32LSISF2026-10-12
10198956388376CARDINAL HEALTHSOPCGTHOMESOPCGTHOME2026-10-12
10198956391239CARDINAL HEALTHSOT12CYMOCSOT12CYMOC2026-10-12
10198956399051CARDINAL HEALTHSUT44BPSCBSUT44BPSCB2026-10-12
10198956421240CARDINAL HEALTHSEY23CTRCPSEY23CTRCP2026-10-12
10198956460393CARDINAL HEALTHSEN30EEPRBSEN30EEPRB2026-10-12
10198956463875CARDINAL HEALTH02-0891H02-0891H2026-10-12
10198956471887CARDINAL HEALTHSCV54VCWMUSCV54VCWMU2026-10-12
10198956491298CARDINAL HEALTH31-1019F31-1019F2026-10-12
10198956493803CARDINAL HEALTHSNE11CR83GSNE11CR83G2026-10-12
10198956507425CARDINAL HEALTHSBA42BPSMBSBA42BPSMB2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956460393CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956519749CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956547698CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956565340CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956579880CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956582613CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956582774CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956584716CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956585652CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956590861CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956592322CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956593572CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956601055CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956604148CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956604261CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-12
10198956439535CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956554122CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956564305CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956568679CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956580374CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956583078CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956589834CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956593671CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956594449CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956594654CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956596689CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956598195CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956598768CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956599284CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06
10198956600492CARDINAL HEALTHCardinal Health 200, LLCOGR2026-10-06