OWELL (UDI OWTL28G-100)

Manufactured by OWELL

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The OWELL (Model/Catalog Number: OWTL28G-100) is a medical device manufactured by OWELL. This product is indexed under FDA Product Code / Category Classification QRK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: OWTL28G-100
Product Code / EMDN: QRK
Device Name: OWELL Twist Top Lancets, 28g | 100 Count
Database Sync Date: 2026-08-09 09:37:40

Full Regulatory Attributes

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{
    "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 OWELL?

The registered manufacturer of record for OWELL is OWELL.

What is the Primary UDI-DI identifier for OWELL?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OWTL28G-100.

What classification code is assigned to this device?

This device is registered under product classification code QRK.

Similar Classification Devices (QRK)

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