FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956568549
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PNDHLMPCL
Catalog number
PNDHLMPCL
Device description
KIT, LAMINECTOMY EHMC
Published
2026-09-25
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956568547PackageGS11In Commercial Distribution
10198956568549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895656854750198956568547
1019895656854910198956568549

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical 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
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
10198956579194CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956581746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956582378CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956584662CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956585751CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956586895CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587335CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587663CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587724CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956588431CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956588622CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956589797CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956589995CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590021CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590250CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10809160538951HalyardAVID MEDICAL, INC.OJG2026-09-24
10198956313897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956488366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956489196CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956502123CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22