FDA.report

CARDINAL HEALTH

Primary DI
50197106205196
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
26-1303E
Catalog number
26-1303E
Device description
LUMBAR PUNCTURE PEDIATRIC TRAY
Published
2023-05-15
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
PWYLumbar puncture tray (adult & pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
PWYLumbar Puncture Tray (Adult & Pediatric)General Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106205196PackageGS112In Commercial Distribution
10197106205198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710620519650197106205196
1019710620519810197106205198

GMDN Terms

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

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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