GUDIDData
gudid Primary ID: 00711136

BioShield (UDI 00711136)

Manufactured by US Endoscopy

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BioShield - Primary ID 00711136

Device Regulatory Overview

The BioShield (Model/Catalog Number: 00711136) is a medical device manufactured by US Endoscopy. This product is indexed under FDA Product Code / Category Classification ODD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
00711136
Product Code / EMDN
ODD
Device Name
The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The BioShield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
Database Sync Date
2026-08-09 09:19:09

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 BioShield?

The registered manufacturer of record for BioShield is US Endoscopy.

What is the Primary UDI-DI identifier for BioShield?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00711136.

What classification code is assigned to this device?

This device is registered under product classification code ODD.

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