FDA.report

CARDINAL HEALTH

Primary DI
50195594780102
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
27-7824C
Catalog number
27-7824C
Device description
MYELOGRAM TRAY
Published
2022-08-31
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
OIPRadiology-diagnostic kit

Product Code Classifications

CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594780102PackageGS116In Commercial Distribution
10195594780104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559478010250195594780102
1019559478010410195594780104

GMDN Terms

TermDefinition
Myelography kitA collection of devices designed for injecting contrast medium into the subarachnoid (intrathecal) space (usually of the lumbar spine) for the purposes of visualizing the spinal canal by radiographic study. It is also referred to as myelogram tray and typically includes a needle, syringe, tubing, contrast medium, and other consumable items. 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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