FDA.report

PaliumNeedle

Primary DI
08052440101979
Brand
PaliumNeedle
Company
MDL SRL
Model
MGK11410
Catalog number
MGK11410
Device description
10CS-DISP.NEEDLE 14GX100mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITH BARD AUTOM. MAGNUM GUN/PALIUM GUN
Published
2017-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MJGDevice, Percutaneous, Biopsy

Product Code Classifications

CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08052440101979PackageGS110In Commercial Distribution
08052440104734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08052440101979080524401019798052440101979
08052440104734080524401047348052440104734

GMDN Terms

TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Device Sizes

TypeValueUnit
Length100Millimeter
Needle Gauge14Gauge

Sterilization Methods

Method

Regulatory Flags

DUNS number
447228586
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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