FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
00887488014770
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PEOCMEBLK
Catalog number
PEOCMEBLK
Device description
MAJOR EAR,KIT
Published
2015-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGREar, nose, and throat surgical tray (kit)

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
50887488014775PackageGS11In Commercial Distribution
00887488014770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088748801477550887488014775
00887488014770008874880147708874880147700887488014770

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

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956541757CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956550568CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956562615CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956583504CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956587465CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956588967CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
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
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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
10198956582859CARDINAL 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