FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
00885425812212
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE21CRDCJ
Catalog number
SNE21CRDCJ
Device description
STERILE RMC CRANIOTOMY PACK
Published
2015-08-31
Public version status
Update
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
50885425812217PackageGS12In Commercial Distribution
00885425812212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088542581221750885425812217
00885425812212008854258122128854258122120885425812212

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 Temperature040 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956454897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956473218CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956475571CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956480629CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956487178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956487536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956489288CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956489325CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956491168CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956493056CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10809160521908HalyardAVID MEDICAL, INC.OJG2026-05-27
10193489375657NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10193489376845NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10080196471096NAMICMEDLINE INDUSTRIES, INC.OJG2026-04-24