gudid
Primary ID: P-104
Prager Shell (UDI P-104)
Manufactured by ESI CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Prager Shell - Primary ID P-104
Device Regulatory Overview
The Prager Shell (Model/Catalog Number: P-104) is a medical device manufactured by ESI CORPORATION. This product is indexed under FDA Product Code / Category Classification ITX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- P-104
- Product Code / EMDN
- ITX
- Device Name
- Quantel Medical
- Database Sync Date
- 2026-08-09 09:18:01
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 Prager Shell?
The registered manufacturer of record for Prager Shell is ESI CORPORATION.
What is the Primary UDI-DI identifier for Prager Shell?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P-104.
What classification code is assigned to this device?
This device is registered under product classification code ITX.
Similar Classification Devices (ITX)
Other Devices by ESI CORPORATION
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