gudid Primary ID: Putty - OTC

enCore Night Guard (UDI Putty - OTC)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The enCore Night Guard (Model/Catalog Number: Putty - OTC) is a medical device manufactured by ENCORE LABORATORY LLC. This product is indexed under FDA Product Code / Category Classification SHI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Putty - OTC
Product Code / EMDN: SHI
Device Name
Database Sync Date: 2026-08-09 09:49:15

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of enCore Night Guard?

The registered manufacturer of record for enCore Night Guard is ENCORE LABORATORY LLC.

What is the Primary UDI-DI identifier for enCore Night Guard?

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

What classification code is assigned to this device?

This device is registered under product classification code SHI.

Similar Classification Devices (SHI)

Other Devices by ENCORE LABORATORY LLC

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint