FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106165492
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE12CR321
Catalog number
SNE12CR321
Device description
CRANIOTOMY PACK
Published
2023-03-03
Public version status
New
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
50197106165490PackageGS11In Commercial Distribution
10197106165492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710616549050197106165490
1019710616549210197106165492

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956260016CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956469617CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956494022CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956497788CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956500228CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956502253CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956514812CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956514843CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956520486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956527683CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956528215CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956528253CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956529298CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956530614CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10197106896327CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956489165CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956491625CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956492141CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956502581CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956518384CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526235CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526501CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956527553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528185CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528437CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528727CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10809160526897HalyardAVID MEDICAL, INC.OJG2026-07-08
10198956416079CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956502062CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956515536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06