FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956534353
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE3VLLBS1
Catalog number
SNE3VLLBS1
Device description
LUMBAR LAMINECTOMY PACK
Published
2026-07-27
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
50198956534351PackageGS12In Commercial Distribution
10198956534353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653435150198956534351
1019895653435310198956534353

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, medicatedA collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528129HalyardAVID MEDICAL, INC.OJG2026-07-30
10809160527887HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527924HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527986HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160528013HalyardAVID MEDICAL, INC.OJG2026-07-28
10809160528037HalyardAVID MEDICAL, INC.OJG2026-07-28
10197106927687CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956337404CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956416444CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956479364CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956480698CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956480919CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956494626CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956500075CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956502611CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956505605CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956510876CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956513204CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956514911CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956516380CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956520066CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956520714CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956524019CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956529700CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956532427CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956532755CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956534285CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956534339CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956537071CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956538436CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27