FDA.reportPublic FDA data

PaliumNeedle

Primary DI
08052440101856
Brand
PaliumNeedle
Company
MDL SRL
Model
MGK11616
Catalog number
MGK11616
Device description
10CS-DISP.NEEDLE 16GX160mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITHBARD 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

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
08052440101856PackageGS110In Commercial Distribution
08052440104659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052440101856080524401018568052440101856
08052440104659080524401046598052440104659

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length160Millimeter
Needle Gauge16Gauge

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056138586109PaliumPLPL2021-05-17
18056138586243MarkPN2015PN20152021-05-17
18056138586250AutoMarkPNA2005PNA20052021-05-17
18056138586267AutoMarkPNA2010PNA20102021-05-17
18056138586274AutoMarkPNA2015PNA20152021-05-17
18056138586304MarkSlimPNS2010PNS20102021-05-17
18056138586311MarkslimPNS2015PNS20152021-05-17
08056138586352RepoMarkPR2005PR20052021-05-17
18056138586366RepoMarkPR2007PR20072021-05-17
18056138586373RepoMarkPR2010PR20102021-05-17
18056138586380RepoMarkPR2015PR20152021-05-17
18056138586397PressToPS0810PS08102021-05-17
18056138586403PressToPS1110PS11102021-05-17
18056138586410PressToPS1115PS11152021-05-17
18056138586427PressToPS1306PS13062021-05-17
18056138586434PressToPS1310PS13102021-05-17
28056138586615ThemyTY1206TY12062021-05-17
28056138586622ThemyTY1209TY12092021-05-17
28056138586639ThemyTY1211TY12112021-05-17
28056138586646ThemyTY1410TY14102021-05-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974405095197CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.MJG2026-05-26
06974405095203CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.MJG2026-05-26
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50198956256048CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-28
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50198956201147CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-25
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04048223128893PrimoCutPajunk GmbH MedizintechnologieMJG2025-06-17
04048223128947Coaxial sleeve Ø 1,50 (17G)Pajunk GmbH MedizintechnologieMJG2025-06-17
04048223131923Coaxial sleeve Ø 1,50 (17G)Pajunk GmbH MedizintechnologieMJG2025-06-17
50198956116564CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-16
50198956084092CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-11
50197106926800CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
50197106927999CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
50198956017533CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
50198956033540CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05