FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439090918
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNECGSPDNI
Catalog number
SNECGSPDNI
Device description
DELNOR SPINE PACK
Published
2018-10-04
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
50888439090916PackageGS11In Commercial Distribution
10888439090918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843909091650888439090916
1088843909091810888439090918

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956336865CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956475106CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956476301CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956490284CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956496064CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956497610CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956498273CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956501737CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956503496CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956332522CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956400726CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956429604CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956450486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956457416CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956460591CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956472167CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956483071CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956486089CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956492516CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956493193CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495111CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495487CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495975CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956498280CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10809160522561HalyardAVID MEDICAL, INC.OJG2026-06-04
10809160522578HalyardAVID MEDICAL, INC.OJG2026-06-04
10809160522615HalyardAVID MEDICAL, INC.OJG2026-06-04
10198956477452CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956483910CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956492257CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03