FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956454897
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PN23CRNLE
Catalog number
PN23CRNLE
Device description
KIT, CRANIOTOMY NEW HAN
Published
2026-06-01
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
50198956454895PackageGS11In Commercial Distribution
10198956454897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895645489550198956454895
1019895645489710198956454897

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
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10193489214383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489218220Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489417609Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489419641Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489422245Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489422719Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489423198Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489426984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489427943Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489444148Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489444605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08