GUDIDData
eudamed_udi Primary ID: 30845854082991

Paradigm Revolution (UDI 30845854082991)

Manufactured by Conmed Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Paradigm Revolution - Primary ID 30845854082991

Device Regulatory Overview

The Paradigm Revolution (Model/Catalog Number: PRTA04) is a medical device manufactured by Conmed Corporation. This product is indexed under FDA Product Code / Category Classification L0908 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-2597-2016 View Full Alert →

Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used f...

πŸ”’ Compromised Lot & Serial Numbers Locked
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ID: Z-2599-2016 View Full Alert →

Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6...

πŸ”’ Compromised Lot & Serial Numbers Locked
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ID: Z-2598-2016 View Full Alert →

Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, ...

πŸ”’ Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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Technical Specifications

Model Number
PRTA04
Product Code / EMDN
L0908
Device Name
Orthopedic, Non-active, Stabilization, Hand, Sterile
Database Sync Date
2026-08-09 16:50:41

Full Regulatory Attributes

πŸ”’ 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 Paradigm Revolution?

The registered manufacturer of record for Paradigm Revolution is Conmed Corporation.

What is the Primary UDI-DI identifier for Paradigm Revolution?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 30845854082991.

What classification code is assigned to this device?

This device is registered under product classification code L0908.

Programmatic Export

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