FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106909348
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE41SPAW3
Catalog number
SNE41SPAW3
Device description
SPINE PACK
Published
2025-01-17
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
50197106909346PackageGS11In Commercial Distribution
10197106909348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710690934650197106909346
1019710690934810197106909348

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It 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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106896327CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956489165CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956491625CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956492141CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956502581CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956518384CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526235CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526501CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956527553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528185CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528437CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528727CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10809160526897HalyardAVID MEDICAL, INC.OJG2026-07-08
10198956416079CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956502062CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956515536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956524873CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956525344CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956527348CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10809160526187HalyardAVID MEDICAL, INC.OJG2026-06-25
10809160526194HalyardAVID MEDICAL, INC.OJG2026-06-25
10809160525999HalyardAVID MEDICAL, INC.OJG2026-06-24
10809160526040HalyardAVID MEDICAL, INC.OJG2026-06-24
10198956340169CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956365674CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956491120CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956502796CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956512085CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956512825CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956513808CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23