gudid
Primary ID: Hard
enCore Night Guard (UDI Hard)
Manufactured by ENCORE LABORATORY LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for enCore Night Guard - Primary ID Hard
Device Regulatory Overview
The enCore Night Guard (Model/Catalog Number: Hard) is a medical device manufactured by ENCORE LABORATORY LLC. This product is indexed under FDA Product Code / Category Classification OBR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Hard
- Product Code / EMDN
- OBR
- Device Name
- Database Sync Date
- 2026-08-09 09:49:15
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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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 Hard.
What classification code is assigned to this device?
This device is registered under product classification code OBR.
Similar Classification Devices (OBR)
Other Devices by ENCORE LABORATORY LLC
Programmatic Export
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JSON API Endpoint