GUDIDData
gudid Primary ID: M205

Monolith InstruZyme conc. (UDI M205)

Manufactured by PRISMAN INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Monolith InstruZyme conc. - Primary ID M205

Device Regulatory Overview

The Monolith InstruZyme conc. (Model/Catalog Number: M205) is a medical device manufactured by PRISMAN INC.. This product is indexed under FDA Product Code / Category Classification FLG within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
M205
Product Code / EMDN
FLG
Device Name
Database Sync Date
2026-08-09 09:11:42

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 Monolith InstruZyme conc.?

The registered manufacturer of record for Monolith InstruZyme conc. is PRISMAN INC..

What is the Primary UDI-DI identifier for Monolith InstruZyme conc.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M205.

What classification code is assigned to this device?

This device is registered under product classification code FLG.

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