GUDIDData
gudid Primary ID: LBGEM05

GEM 21S (UDI LBGEM05)

Manufactured by LYNCH BIOLOGICS, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GEM 21S - Primary ID LBGEM05

Device Regulatory Overview

The GEM 21S (Model/Catalog Number: LBGEM05) is a medical device manufactured by LYNCH BIOLOGICS, LLC. This product is indexed under FDA Product Code / Category Classification NPZ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
LBGEM05
Product Code / EMDN
NPZ
Device Name
Growth-Factor Enhanced Matrix for Periodontal Regeneration
Database Sync Date
2026-08-09 09:37:52

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 GEM 21S?

The registered manufacturer of record for GEM 21S is LYNCH BIOLOGICS, LLC.

What is the Primary UDI-DI identifier for GEM 21S?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is LBGEM05.

What classification code is assigned to this device?

This device is registered under product classification code NPZ.

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