FDA.reportPublic FDA data

PALIUM COAXIAL

Primary DI
08032986351410
Brand
PALIUM COAXIAL
Company
M.D.L. S.R.L.
Model
MGC1410
Catalog number
MGC1410
Device description
GUILLOTINE NEEDLE 14Gx100mm FORSOFT TISSUE, PALIUM AND MAGNUMBARD TM WITH COAXIAL 13Gx75mm
Published
2018-06-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MJGDevice, Percutaneous, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08032986351410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032986351410080329863514108032986351410

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
447228586
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057276004814Cell-HarvestORPSH1D21110PSH1D211102025-04-29
08057276004821Bone-HarvestORPS0810PS08102025-04-29
08056138586338MarkXPNX2010PNX20102025-02-28
08057276004715MarkXPNX2015PNX20152025-02-28
08056138586109PaliumPLPL2021-05-17
08052440107018PaliumPLPL2017-01-05
08032986351427FastCutMMGC1413MGC14132017-02-21
08032986351533FastCutMMGC1825MGC18252017-02-21
08058341215203PALIUM COAXIALMGC1210MGC12102018-06-07
08032986359416AutoMarkPNA2005PNA20052017-01-05
08032986359447AutoMarkPNAX2005PNAX20052017-01-05
08032986359867RepoMarkPR2005PR20052017-01-05
08052440107407MarkPNX2007PNX20072017-06-05
08052440107445MarkPNX2010PNX20102017-02-21
08052440107469MarkPN2012PN20122017-03-23
08052440107759AutoMarkPNAX2010PNAX20102017-06-05
08052440107841RepoMarkPR2007PR20072017-01-05
08052440107858RepoMarkPR2010PR20102017-06-05
08056138586222MarkPN2010PN20102021-05-14
08056138586239MarkPN2012PN20122021-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197106926802CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
10197106927991CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
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10198956015722CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-09
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10198956001718CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-07
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10197106945278CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-25
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10197106914250CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-30
10197106905951CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-17
10197106887622CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-15