GUDIDData
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gudid Primary ID: SP-002-1F

OmniBone Power Driver (UDI SP-002-1F)

Manufactured by Varian Medical Systems, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OmniBone Power Driver - Primary ID SP-002-1F

Device Regulatory Overview

The OmniBone Power Driver (Model/Catalog Number: SP-002-1F) is a medical device manufactured by Varian Medical Systems, Inc.. This product is indexed under FDA Product Code / Category Classification KNW 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-0990-2017 View Full Alert →

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🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0760-2013 View Full Alert →

Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachyth...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1324-2013 View Full Alert →

Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed do...

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

Model Number
SP-002-1F
Product Code / EMDN
KNW
Device Name
Database Sync Date
2026-08-09 09:22:18

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 OmniBone Power Driver?

The registered manufacturer of record for OmniBone Power Driver is Varian Medical Systems, Inc..

What is the Primary UDI-DI identifier for OmniBone Power Driver?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SP-002-1F.

What classification code is assigned to this device?

This device is registered under product classification code KNW.

Similar Classification Devices (KNW)

Other Devices by Varian Medical Systems, Inc.

Programmatic Export

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

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