FDA.report

CARDINAL HEALTH

Primary DI
50198956238853
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE31NM98G
Catalog number
SNE31NM98G
Device description
NEURO MED PACK 20010798
Published
2025-11-17
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

Related Records

Product Codes

CodeName
OJGNeurological tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50198956238853PackageGS11In Commercial Distribution
10198956238855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019895623885350198956238853
1019895623885510198956238855

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

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

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