GUDIDData
eudamed_udi Primary ID: 00884838002777

3-Wire Lead Set and Plug Snap IEC (UDI 00884838002777)

Manufactured by Philips Medical Systems

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 3-Wire Lead Set and Plug Snap IEC - Primary ID 00884838002777

Device Regulatory Overview

The 3-Wire Lead Set and Plug Snap IEC (Model/Catalog Number: M3528A) is a medical device manufactured by Philips Medical Systems. This product is indexed under FDA Product Code / Category Classification Z12030585 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-0745-2016 View Full Alert →

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0010-2017 View Full Alert →

Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0012-2017 View Full Alert →

Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body...

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

Technical Specifications

Model Number
M3528A
Product Code / EMDN
Z12030585
Device Name
Cables and Cable Accessories
Database Sync Date
2026-08-09 16:28:57

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 3-Wire Lead Set and Plug Snap IEC?

The registered manufacturer of record for 3-Wire Lead Set and Plug Snap IEC is Philips Medical Systems.

What is the Primary UDI-DI identifier for 3-Wire Lead Set and Plug Snap IEC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00884838002777.

What classification code is assigned to this device?

This device is registered under product classification code Z12030585.

Programmatic Export

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