GUDIDData
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classification Primary ID: NGL

Test, Opiates, Over The Counter (UDI NGL)

Manufactured by

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Test, Opiates, Over The Counter - Primary ID NGL

Device Regulatory Overview

The Test, Opiates, Over The Counter (Model/Catalog Number: Unspecified) is a medical device manufactured by . This product is indexed under FDA Product Code / Category Classification NGL 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 →

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🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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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...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-2793-2026 View Full Alert →

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

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
N/A
Product Code / EMDN
NGL
Device Name
Test, Opiates, Over The Counter
Database Sync Date
2026-08-09 09:00:27

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 Test, Opiates, Over The Counter?

The registered manufacturer of record for Test, Opiates, Over The Counter is .

What is the Primary UDI-DI identifier for Test, Opiates, Over The Counter?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is NGL.

What classification code is assigned to this device?

This device is registered under product classification code NGL.

Similar Classification Devices (NGL)

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Programmatic Export

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