GUDIDData
gudid Primary ID: 01-1000-003

Compressor / Distractor (UDI 01-1000-003)

Manufactured by Treace Medical Concepts, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Compressor / Distractor - Primary ID 01-1000-003

Device Regulatory Overview

The Compressor / Distractor (Model/Catalog Number: 01-1000-003) is a medical device manufactured by Treace Medical Concepts, Inc.. This product is indexed under FDA Product Code / Category Classification HWN within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2718-2024 View Full Alert →

Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component....

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Technical Specifications

Model Number
01-1000-003
Product Code / EMDN
HWN
Device Name
Compressor / Distractor
Database Sync Date
2026-08-09 09:12:32

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 Compressor / Distractor?

The registered manufacturer of record for Compressor / Distractor is Treace Medical Concepts, Inc..

What is the Primary UDI-DI identifier for Compressor / Distractor?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 01-1000-003.

What classification code is assigned to this device?

This device is registered under product classification code HWN.

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