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enforcement Primary ID: Z-1171-2023

Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. (UDI Z-1171-2023)

Manufactured by Summit Medical, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. - Primary ID Z-1171-2023

Device Regulatory Overview

The Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. (Model/Catalog Number: Unspecified) is a medical device manufactured by Summit Medical, LLC. This product is indexed under FDA Product Code / Category Classification Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

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Technical Specifications

Model Number
N/A
Device Name
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Database Sync Date
2026-08-09 10:06:52

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 Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.?

The registered manufacturer of record for Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. is Summit Medical, LLC.

What is the Primary UDI-DI identifier for Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-1171-2023.

What classification code is assigned to this device?

This device is registered under product classification code Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340.

Other Devices by Summit Medical, LLC

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