FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439863886
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE69CRCIZ
Catalog number
SNE69CRCIZ
Device description
CRANIOTOMY PACK
Published
2020-07-23
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
50888439863886PackageGS11In Commercial Distribution
10888439863888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843986388650888439863886
1088843986388810888439863888

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

Sterilization Methods#

Method table
Method

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
10198956537798CARDINAL HEALTHSOP53TOWRGSOP53TOWRG2026-10-13
10198956539914CARDINAL HEALTHSOP48EX85ASOP48EX85A2026-10-13
10198956541658CARDINAL HEALTHSAN1DRPUNCSAN1DRPUNC2026-10-13
10198956545182CARDINAL HEALTHSOP53SLVLLSOP53SLVLL2026-10-13
10198956549050CARDINAL HEALTHSOP45THBMJSOP45THBMJ2026-10-13
10198956559516CARDINAL HEALTH08-0857C08-0857C2026-10-13
10198956562950CARDINAL HEALTHSBA43MPMADSBA43MPMAD2026-10-13
10198956563223CARDINAL HEALTHSOP42ARBTHSOP42ARBTH2026-10-13
10198956564237CARDINAL HEALTHSEY45BPPAESEY45BPPAE2026-10-13
10198956570740CARDINAL HEALTHSEN48ESSNASEN48ESSNA2026-10-13
10198956570993CARDINAL HEALTH34-2403F34-2403F2026-10-13
10198956573024CARDINAL HEALTHSMA54MGFMPSMA54MGFMP2026-10-13
10198956577084CARDINAL HEALTH08-0857D08-0857D2026-10-13
10198956578753CARDINAL HEALTH34-7753A34-7753A2026-10-13
10198956588721CARDINAL HEALTHSMA40DERWDSMA40DERWD2026-10-13
10198956589810CARDINAL HEALTHSBAOCRPS30SBAOCRPS302026-10-13
10198956592698CARDINAL HEALTHSAN53ANOV6SAN53ANOV62026-10-13
10198956593770CARDINAL HEALTHSOTOCURGR3SOTOCURGR32026-10-13
10198956595071CARDINAL HEALTH31-826AW31-826AW2026-10-13
10198956597891CARDINAL HEALTHSBA43RPUSESBA43RPUSE2026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956603240CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956604025CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956493803CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956542174CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956556423CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956561304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956568105CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956571211CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956573277CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956578746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956594289CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956598294CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600140CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601109CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601192CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601406CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601741CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956602045CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10809160540190HalyardAVID MEDICAL, INC.OJG2026-10-08
10198956141018CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956314351CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956458925CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541627CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956544918CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956550681CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956559790CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956561342CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06