FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956554825
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE57SP026
Catalog number
SNE57SP026
Device description
SPINE SURG SMC SYB PACK
Published
2026-08-18
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
50198956554823PackageGS12In Commercial Distribution
10198956554825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895655482350198956554823
1019895655482510198956554825

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 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
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160530696HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530757HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530764HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530832HalyardAVID MEDICAL, INC.OJG2026-08-19
10198956469990CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956556300CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956556317CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956557697CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10809160530269HalyardAVID MEDICAL, INC.OJG2026-08-18
10809160530559HalyardAVID MEDICAL, INC.OJG2026-08-18
10198956533899CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956535961CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956544581CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956548756CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956553231CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10809160528396HalyardAVID MEDICAL, INC.OJG2026-08-03
10809160528587HalyardAVID MEDICAL, INC.OJG2026-08-03
10198956327603CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956353961CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956504936CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956506947CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956513570CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956521346CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956524125CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956531130CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534131CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534674CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956538672CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542297CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542921CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31