FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956619326
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE4JFSC11
Catalog number
SNE4JFSC11
Device description
PK FUSION SPINAL CM
Published
2026-10-23
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
50198956619324PackageGS11In Commercial Distribution
10198956619326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895661932450198956619324
1019895661932610198956619326

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar puncture kitA collection of devices intended for transient percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to obtain a sample of cerebrospinal fluid (CSF). Typical components include a spinal needle and collection tubes for the CSF; a drainage catheter is not included. 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
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956332553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956504899CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956548923CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956562936CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956570702CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956595934CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956597020CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956600072CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956602588CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956604445CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956609204CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956611399CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
10198956612594CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-23
B098AMS12195E0Aligned Medical SolutionsAligned Medical SolutionsOJG2026-10-23
10198956038127CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956268111CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956537439CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956562660CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956565586CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956592209CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956598027CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956599321CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956604087CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956604230CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956606777CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956608115CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956608405CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956608665CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956610224CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956612297CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19