FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956620933
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE53CNV12
Catalog number
SNE53CNV12
Device description
CRANI PACK
Published
2026-10-26
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
50198956620931PackageGS13In Commercial Distribution
10198956620933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895662093150198956620931
1019895662093310198956620933

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 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
00885380173700Curity1806G1806G2026-10-26
10192253010015Kangaroo7761507761502026-10-26
10198956294127CARDINAL HEALTHSOPHDTHWWCSOPHDTHWWC2026-10-26
10198956515376CARDINAL HEALTHSBA69FFKWRSBA69FFKWR2026-10-26
10198956516342CARDINAL HEALTHSMA54GLPOISMA54GLPOI2026-10-26
10198956519138CARDINAL HEALTHSMA55CPYKFSMA55CPYKF2026-10-26
10198956542006CARDINAL HEALTH20-485AI20-485AI2026-10-26
10198956555839CARDINAL HEALTHAMN696315EAMN696315E2026-10-26
10198956562905CARDINAL HEALTHSEY57KC00GSEY57KC00G2026-10-26
10198956565784CARDINAL HEALTHSNEOCSPSBCSNEOCSPSBC2026-10-26
10198956566705CARDINAL HEALTHPN41LMLAKPN41LMLAK2026-10-26
10198956568884CARDINAL HEALTH27-9143M27-9143M2026-10-26
10198956573437CARDINAL HEALTHSAN12AIUVFSAN12AIUVF2026-10-26
10198956575028CARDINAL HEALTHSMA73UGKSISMA73UGKSI2026-10-26
10198956576940CARDINAL HEALTHSOP69SH45CSOP69SH45C2026-10-26
10198956577107CARDINAL HEALTHSEN4AEAJHWSEN4AEAJHW2026-10-26
10198956577282CARDINAL HEALTHSBAOCMBKCRSBAOCMBKCR2026-10-26
10198956578869CARDINAL HEALTHSBAOCMJWYJSBAOCMJWYJ2026-10-26
10198956590359CARDINAL HEALTHSBA4QFLFPCSBA4QFLFPC2026-10-26
10198956591981CARDINAL HEALTHSOP69EEKRESOP69EEKRE2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956565784CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-26
10198956566705CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-26
10198956598485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-26
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
10198956619326CARDINAL 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