FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956543577
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE21CRCAH
Catalog number
SNE21CRCAH
Device description
ST JOSEPHS CRANIOTOMY TRAY
Published
2026-10-15
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
50198956543575PackageGS12In Commercial Distribution
10198956543577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895654357550198956543575
1019895654357710198956543577

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
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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15
10198956570177CARDINAL HEALTHSOP54TJFMQSOP54TJFMQ2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956572287CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-15
10198956592230CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-15
10198956603240CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956604025CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956493803CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956542174CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956556423CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956561304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956568105CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956571211CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956573277CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956578746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956594289CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956598294CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600140CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601109CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601192CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601406CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601741CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956602045CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10809160540190HalyardAVID MEDICAL, INC.OJG2026-10-08
10198956141018CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956314351CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956458925CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541627CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956544918CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956550681CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06