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enforcement Primary ID: Z-2492-2021

Soft Tissue Biopsy Needles (UDI Z-2492-2021)

Manufactured by M.D.L. S.r.l.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Soft Tissue Biopsy Needles - Primary ID Z-2492-2021

Device Regulatory Overview

The Soft Tissue Biopsy Needles (Model/Catalog Number: Unspecified) is a medical device manufactured by M.D.L. S.r.l.. This product is indexed under FDA Product Code / Category Classification Model MGK11210, Lot Numbers: 5216C Model MGK11410, Lot Numbers: 5216C, 1217B, 3620D Model MGK11413, Lot Numbers: 5216C Model MGK11415, Lot Numbers: 3620D Model MGK11610, Lot Numbers: 5216C, 3620D Model MGK11615, Lot Numbers: 3620D Model MGK11616, Lot Numbers: 5216C, 1217B Model MGK11620, Lot Numbers: 1617A Model MGK11810, Lot Numbers: 5216C Model MGK11816, Lot Numbers: 5216C Model MGK11820, Lot Numbers: 5216C, 1217B, 4617 Model MGK11825, Lot Numbers: 5216C, 1217B, 3620D, 3620E Model PD01415, Lot Numbers: 3620D, 3620E Model PD01416, Lot Numbers: 5216C, 1417A Model PD01420, Lot Numbers: 5216C Model PD01610, Lot Numbers: 5216C, 0817A, 0818, 1618A, 1918A, 3620D, 3620E Model PD01615, Lot Numbers: 3620D, 3620E Model PD01616, Lot Numbers: 5216C, 1417A Model PD01620, Lot Numbers: 5216C Model PD01810, Lot Numbers: 5216C, 0817A, 0817A, 1617A, 0818, 1618A, 1918A Model PD01816, Lot Numbers: 5216C, 0817A, 0817A, 1617A Model PD01820, Lot Numbers: 5216C, 2217A, 2217A Model PD02007, Lot Numbers: 1617A, 2217A, 0119 Model PD02010, Lot Numbers: 5216C, 0817A, 2217A, 1918A Model PD02016, Lot Numbers: 5216C, 0817A, 2217A Model PD02020, Lot Numbers: 5216C, 0817A Model PD0PP1407, Lot Numbers: 0718 Model PD0PP1410, Lot Numbers: 5216C, 3620D, 3620E Model PD0PP1415, Lot Numbers: 3620D, 3620E Model PD0PP1416, Lot Numbers: 5216C Model PD0PP1420, Lot Numbers: 5216C Model PD0PP1610, Lot Numbers: 5216C, 4018, 1119A, 3620D, 3620E Model PD0PP1615, Lot Numbers: 3620D, 3620E, 4220C Model PD0PP1616, Lot Numbers: 5216C, 1119A Model PD0PP1620, Lot Numbers: 5216C Model PD0PP1807, Lot Numbers: 4018, 0219 Model PD0PP1810, Lot Numbers: 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1815, Lot Numbers: 1417C Model PD0PP1816, Lot Numbers: 5216C, 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1820, Lot Numbers: 5216C, 1417A, 2217A, 2618B, 0219, 1119A Model PD0PP1825, Lot Numbers: 5216C, 1417A Model PD0PP2007, Lot Numbers: 1617A, 0119, 0219 Model PD0PP2010, Lot Numbers: 0417, 1417A, 2217A, 0918, 0219 Model PD0PP2016, Lot Numbers: 1417A, 2217A, 0818A, 0818B, 1218A, 0219, 1119A Model PD0PP2020, Lot Numbers: 1417A, 2217A, 0219, 1119A Model TY1410, Lot Numbers: 5216C, 1417A, 1817, 1618A, 3620D Model TY1412, Lot Numbers: 1617A Model TY1416, Lot Numbers: 5216C, 1417A Model TY1420, Lot Numbers: 1417A Model TY1610, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1612, Lot Numbers: 1618A Model TY1616, Lot Numbers: 5216C, 0817 Model TY1620, Lot Numbers: 5216C Model TY1810, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1812, Lot Numbers: 2217, 1618A Model TY1816, Lot Numbers: 5216C Model TY1820, Lot Numbers: 5216C, 1417A, 1417C, 0818, 1618A, 1918A Model TY1825, Lot Numbers: 5216C, 2217A, 1618A, 3620D Model TY1830, Lot Numbers: 1618A Model TY2010, Lot Numbers: 5216C Model TY2016, Lot Numbers: 5216C Model TY2020, Lot Numbers: 5216C, 1417A Model TYC1410, Lot Numbers: 5216C, 1417A Model TYC1412, Lot Numbers: 1617A Model TYC1416, Lot Numbers: 5216C Model TYC1810, Lot Numbers: 5216C, 2217A Model TYC1812, Lot Numbers: 2217 Model TYC1816, Lot Numbers: 5216C, 2217A Model TYC1820, Lot Numbers: 1417A, 2117A Model TYC2010, Lot Numbers: 5216C, 2217A Model TYC2016, Lot Numbers: 5216C, 2217A Model TYC2020, Lot Numbers: 1417A, 2117A, 2217A within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2753-2026 View Full Alert →

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...

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ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

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ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

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Technical Specifications

Model Number
N/A
Product Code / EMDN
Model MGK11210, Lot Numbers: 5216C Model MGK11410, Lot Numbers: 5216C, 1217B, 3620D Model MGK11413, Lot Numbers: 5216C Model MGK11415, Lot Numbers: 3620D Model MGK11610, Lot Numbers: 5216C, 3620D Model MGK11615, Lot Numbers: 3620D Model MGK11616, Lot Numbers: 5216C, 1217B Model MGK11620, Lot Numbers: 1617A Model MGK11810, Lot Numbers: 5216C Model MGK11816, Lot Numbers: 5216C Model MGK11820, Lot Numbers: 5216C, 1217B, 4617 Model MGK11825, Lot Numbers: 5216C, 1217B, 3620D, 3620E Model PD01415, Lot Numbers: 3620D, 3620E Model PD01416, Lot Numbers: 5216C, 1417A Model PD01420, Lot Numbers: 5216C Model PD01610, Lot Numbers: 5216C, 0817A, 0818, 1618A, 1918A, 3620D, 3620E Model PD01615, Lot Numbers: 3620D, 3620E Model PD01616, Lot Numbers: 5216C, 1417A Model PD01620, Lot Numbers: 5216C Model PD01810, Lot Numbers: 5216C, 0817A, 0817A, 1617A, 0818, 1618A, 1918A Model PD01816, Lot Numbers: 5216C, 0817A, 0817A, 1617A Model PD01820, Lot Numbers: 5216C, 2217A, 2217A Model PD02007, Lot Numbers: 1617A, 2217A, 0119 Model PD02010, Lot Numbers: 5216C, 0817A, 2217A, 1918A Model PD02016, Lot Numbers: 5216C, 0817A, 2217A Model PD02020, Lot Numbers: 5216C, 0817A Model PD0PP1407, Lot Numbers: 0718 Model PD0PP1410, Lot Numbers: 5216C, 3620D, 3620E Model PD0PP1415, Lot Numbers: 3620D, 3620E Model PD0PP1416, Lot Numbers: 5216C Model PD0PP1420, Lot Numbers: 5216C Model PD0PP1610, Lot Numbers: 5216C, 4018, 1119A, 3620D, 3620E Model PD0PP1615, Lot Numbers: 3620D, 3620E, 4220C Model PD0PP1616, Lot Numbers: 5216C, 1119A Model PD0PP1620, Lot Numbers: 5216C Model PD0PP1807, Lot Numbers: 4018, 0219 Model PD0PP1810, Lot Numbers: 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1815, Lot Numbers: 1417C Model PD0PP1816, Lot Numbers: 5216C, 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1820, Lot Numbers: 5216C, 1417A, 2217A, 2618B, 0219, 1119A Model PD0PP1825, Lot Numbers: 5216C, 1417A Model PD0PP2007, Lot Numbers: 1617A, 0119, 0219 Model PD0PP2010, Lot Numbers: 0417, 1417A, 2217A, 0918, 0219 Model PD0PP2016, Lot Numbers: 1417A, 2217A, 0818A, 0818B, 1218A, 0219, 1119A Model PD0PP2020, Lot Numbers: 1417A, 2217A, 0219, 1119A Model TY1410, Lot Numbers: 5216C, 1417A, 1817, 1618A, 3620D Model TY1412, Lot Numbers: 1617A Model TY1416, Lot Numbers: 5216C, 1417A Model TY1420, Lot Numbers: 1417A Model TY1610, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1612, Lot Numbers: 1618A Model TY1616, Lot Numbers: 5216C, 0817 Model TY1620, Lot Numbers: 5216C Model TY1810, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1812, Lot Numbers: 2217, 1618A Model TY1816, Lot Numbers: 5216C Model TY1820, Lot Numbers: 5216C, 1417A, 1417C, 0818, 1618A, 1918A Model TY1825, Lot Numbers: 5216C, 2217A, 1618A, 3620D Model TY1830, Lot Numbers: 1618A Model TY2010, Lot Numbers: 5216C Model TY2016, Lot Numbers: 5216C Model TY2020, Lot Numbers: 5216C, 1417A Model TYC1410, Lot Numbers: 5216C, 1417A Model TYC1412, Lot Numbers: 1617A Model TYC1416, Lot Numbers: 5216C Model TYC1810, Lot Numbers: 5216C, 2217A Model TYC1812, Lot Numbers: 2217 Model TYC1816, Lot Numbers: 5216C, 2217A Model TYC1820, Lot Numbers: 1417A, 2117A Model TYC2010, Lot Numbers: 5216C, 2217A Model TYC2016, Lot Numbers: 5216C, 2217A Model TYC2020, Lot Numbers: 1417A, 2117A, 2217A
Device Name
Soft Tissue Biopsy Needles
Database Sync Date
2026-08-09 10:06:56

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Soft Tissue Biopsy Needles?

The registered manufacturer of record for Soft Tissue Biopsy Needles is M.D.L. S.r.l..

What is the Primary UDI-DI identifier for Soft Tissue Biopsy Needles?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2492-2021.

What classification code is assigned to this device?

This device is registered under product classification code Model MGK11210, Lot Numbers: 5216C Model MGK11410, Lot Numbers: 5216C, 1217B, 3620D Model MGK11413, Lot Numbers: 5216C Model MGK11415, Lot Numbers: 3620D Model MGK11610, Lot Numbers: 5216C, 3620D Model MGK11615, Lot Numbers: 3620D Model MGK11616, Lot Numbers: 5216C, 1217B Model MGK11620, Lot Numbers: 1617A Model MGK11810, Lot Numbers: 5216C Model MGK11816, Lot Numbers: 5216C Model MGK11820, Lot Numbers: 5216C, 1217B, 4617 Model MGK11825, Lot Numbers: 5216C, 1217B, 3620D, 3620E Model PD01415, Lot Numbers: 3620D, 3620E Model PD01416, Lot Numbers: 5216C, 1417A Model PD01420, Lot Numbers: 5216C Model PD01610, Lot Numbers: 5216C, 0817A, 0818, 1618A, 1918A, 3620D, 3620E Model PD01615, Lot Numbers: 3620D, 3620E Model PD01616, Lot Numbers: 5216C, 1417A Model PD01620, Lot Numbers: 5216C Model PD01810, Lot Numbers: 5216C, 0817A, 0817A, 1617A, 0818, 1618A, 1918A Model PD01816, Lot Numbers: 5216C, 0817A, 0817A, 1617A Model PD01820, Lot Numbers: 5216C, 2217A, 2217A Model PD02007, Lot Numbers: 1617A, 2217A, 0119 Model PD02010, Lot Numbers: 5216C, 0817A, 2217A, 1918A Model PD02016, Lot Numbers: 5216C, 0817A, 2217A Model PD02020, Lot Numbers: 5216C, 0817A Model PD0PP1407, Lot Numbers: 0718 Model PD0PP1410, Lot Numbers: 5216C, 3620D, 3620E Model PD0PP1415, Lot Numbers: 3620D, 3620E Model PD0PP1416, Lot Numbers: 5216C Model PD0PP1420, Lot Numbers: 5216C Model PD0PP1610, Lot Numbers: 5216C, 4018, 1119A, 3620D, 3620E Model PD0PP1615, Lot Numbers: 3620D, 3620E, 4220C Model PD0PP1616, Lot Numbers: 5216C, 1119A Model PD0PP1620, Lot Numbers: 5216C Model PD0PP1807, Lot Numbers: 4018, 0219 Model PD0PP1810, Lot Numbers: 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1815, Lot Numbers: 1417C Model PD0PP1816, Lot Numbers: 5216C, 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1820, Lot Numbers: 5216C, 1417A, 2217A, 2618B, 0219, 1119A Model PD0PP1825, Lot Numbers: 5216C, 1417A Model PD0PP2007, Lot Numbers: 1617A, 0119, 0219 Model PD0PP2010, Lot Numbers: 0417, 1417A, 2217A, 0918, 0219 Model PD0PP2016, Lot Numbers: 1417A, 2217A, 0818A, 0818B, 1218A, 0219, 1119A Model PD0PP2020, Lot Numbers: 1417A, 2217A, 0219, 1119A Model TY1410, Lot Numbers: 5216C, 1417A, 1817, 1618A, 3620D Model TY1412, Lot Numbers: 1617A Model TY1416, Lot Numbers: 5216C, 1417A Model TY1420, Lot Numbers: 1417A Model TY1610, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1612, Lot Numbers: 1618A Model TY1616, Lot Numbers: 5216C, 0817 Model TY1620, Lot Numbers: 5216C Model TY1810, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1812, Lot Numbers: 2217, 1618A Model TY1816, Lot Numbers: 5216C Model TY1820, Lot Numbers: 5216C, 1417A, 1417C, 0818, 1618A, 1918A Model TY1825, Lot Numbers: 5216C, 2217A, 1618A, 3620D Model TY1830, Lot Numbers: 1618A Model TY2010, Lot Numbers: 5216C Model TY2016, Lot Numbers: 5216C Model TY2020, Lot Numbers: 5216C, 1417A Model TYC1410, Lot Numbers: 5216C, 1417A Model TYC1412, Lot Numbers: 1617A Model TYC1416, Lot Numbers: 5216C Model TYC1810, Lot Numbers: 5216C, 2217A Model TYC1812, Lot Numbers: 2217 Model TYC1816, Lot Numbers: 5216C, 2217A Model TYC1820, Lot Numbers: 1417A, 2117A Model TYC2010, Lot Numbers: 5216C, 2217A Model TYC2016, Lot Numbers: 5216C, 2217A Model TYC2020, Lot Numbers: 1417A, 2117A, 2217A.

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