FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106716227
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE11CR418
Catalog number
SNE11CR418
Device description
CRANIOTOMY PACK
Published
2024-07-10
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
50197106716227PackageGS11In Commercial Distribution
10197106716229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710671622750197106716227
1019710671622910197106716229

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956376069CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956431744CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956435667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956437463CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956445888CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956462342CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956463486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956475625CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956477087CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956484702CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956485044CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956486515CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
50198956335569CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956359046CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956425833CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956427448CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50197106906055CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50197106926794CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956221060CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956292541CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956311020CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956313123CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956322132CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956323429CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956323665CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956324198CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956327106CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956329278CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956334463CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956334746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23