GUDIDData
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eudamed_udi Primary ID: 10845854034705

CONCEPT GRAFIX (UDI 10845854034705)

Manufactured by Conmed Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CONCEPT GRAFIX - Primary ID 10845854034705

Device Regulatory Overview

The CONCEPT GRAFIX (Model/Catalog Number: CR8901) is a medical device manufactured by Conmed Corporation. This product is indexed under FDA Product Code / Category Classification L0318 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...

🔒 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...

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

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

Technical Specifications

Model Number
CR8901
Product Code / EMDN
L0318
Device Name
Orthopedic, Non-active, Reamer, Disposable, Coring
Database Sync Date
2026-08-09 16:29:30

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 CONCEPT GRAFIX?

The registered manufacturer of record for CONCEPT GRAFIX is Conmed Corporation.

What is the Primary UDI-DI identifier for CONCEPT GRAFIX?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10845854034705.

What classification code is assigned to this device?

This device is registered under product classification code L0318.

Similar Classification Devices (L0318)

Other Devices by Conmed Corporation

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

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