FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439495858
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PN14NSURJ
Catalog number
PN14NSURJ
Device description
KIT, NEURO SPINE
Published
2019-06-17
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
50888439495858PackageGS12In Commercial Distribution
10888439495850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843949585850888439495858
1088843949585010888439495850

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956402416CARDINAL HEALTHSOP13OHEXESOP13OHEXE2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956559790CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956561342CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956565968CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956587519CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956588769CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956590441CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956590571CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956590649CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956595101CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956596160CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956596269CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956596375CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956598201CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956598331CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956598393CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956600300CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10809160539934HalyardAVID MEDICAL, INC.OJG2026-10-06
10809160539866HalyardAVID MEDICAL, INC.OJG2026-10-05
10198956379510CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956435643CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956507920CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956515635CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956541511CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30