FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956498280
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE32CRS25
Catalog number
SNE32CRS25
Device description
CRANIOTOMY PACK
Published
2026-06-05
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
50198956498288PackageGS12In Commercial Distribution
10198956498280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649828850198956498288
1019895649828010198956498280

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
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956332522CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956400726CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956429604CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956450486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956457416CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956460591CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956472167CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956483071CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956486089CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956492516CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956493193CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495111CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495487CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495975CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10809160522561HalyardAVID MEDICAL, INC.OJG2026-06-04
10809160522578HalyardAVID MEDICAL, INC.OJG2026-06-04
10809160522615HalyardAVID MEDICAL, INC.OJG2026-06-04
10198956477452CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956483910CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956492257CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956496842CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956496859CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956498235CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956499478CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10809160522417HalyardAVID MEDICAL, INC.OJG2026-06-02
10198956352711CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956362611CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956384422CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956400238CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956450530CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01