FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
00885425598826
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PN42CAVCE
Catalog number
PN42CAVCE
Device description
KIT,CRANIOTOMY,SFC
Published
2015-10-12
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425598821PackageGS13In Commercial Distribution
00885425598826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088542559882150885425598821
00885425598826008854255988268854255988260885425598826

GMDN Terms#

Term, Definition table
TermDefinition
Craniotomy kitA collection of various sterile basic instruments, dressings and the necessary materials used to perform a craniotomy procedure. It typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals. 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
No 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
B098AMS14766C0Aligned Medical SolutionsAligned Medical SolutionsOJG2026-09-26
10198956466838CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956497382CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956502604CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956513143CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956553910CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956559752CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956565616CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956567818CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956568549CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
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10198956590021CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590250CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
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10198956313897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956488366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956489196CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22