FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956570313
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE32CRS27
Catalog number
SNE32CRS27
Device description
CRANIOTOMY PACK
Published
2026-09-04
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
50198956570311PackageGS12In Commercial Distribution
10198956570313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657031150198956570311
1019895657031310198956570313

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956475113CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956486362CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956491304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956518667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956554948CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956555389CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956559691CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956559974CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956560895CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562509CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562707CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562790CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956563186CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956563575CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956569126CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956569751CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570092CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570139CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571686CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571716CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571761CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956572386CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956572485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956573147CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956573598CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956573611CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10809160532812HalyardAVID MEDICAL, INC.OJG2026-09-04
10198956373105CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-26
10198956491618CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-26