FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106520451
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE37CRSJ8
Catalog number
SNE37CRSJ8
Device description
CRANIOTOMY PACK
Published
2023-12-27
Public version status
New
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
50197106520459PackageGS12In Commercial Distribution
10197106520451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710652045950197106520459
1019710652045110197106520451

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.

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527610HALYARDAVID MEDICAL, INC.OJG2026-07-21
10198956175303CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956395435CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956398900CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956402706CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956415256CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956483385CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956502574CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956506541CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956508002CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956508040CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956512467CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956512931CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956513198CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956513525CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956514928CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956515550CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956516236CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525290CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525436CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525696CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527577CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527775CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527812CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527881CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528024CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528871CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956529120CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956530515CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20