GUDIDData
eudamed_udi Primary ID: +M483GRAAC1250

ROTAX STEM REAMER (UDI +M483GRAAC1250)

Manufactured by groupe lépine

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ROTAX STEM REAMER - Primary ID +M483GRAAC1250

Device Regulatory Overview

The ROTAX STEM REAMER (Model/Catalog Number: GRAAC125) is a medical device manufactured by groupe lépine. This product is indexed under FDA Product Code / Category Classification L091102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
GRAAC125
Product Code / EMDN
L091102
Device Name
Class Ir Instrument
Database Sync Date
2026-08-09 16:29:11

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 ROTAX STEM REAMER?

The registered manufacturer of record for ROTAX STEM REAMER is groupe lépine.

What is the Primary UDI-DI identifier for ROTAX STEM REAMER?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is +M483GRAAC1250.

What classification code is assigned to this device?

This device is registered under product classification code L091102.

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