gudid
Primary ID: 473005
EPITEX (UDI 473005)
Manufactured by Gc America Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EPITEX - Primary ID 473005
Device Regulatory Overview
The EPITEX (Model/Catalog Number: 473005) is a medical device manufactured by Gc America Inc.. This product is indexed under FDA Product Code / Category Classification EHM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 473005
- Product Code / EMDN
- EHM
- Device Name
- EPITEX Starter package Contains: 1 Reel each of Coarse, Medium, Fine & Extra Fine strips 5mm wide, 1 Reel of Translucent matrix strip, work station
- Database Sync Date
- 2026-08-09 09:03:07
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 EPITEX?
The registered manufacturer of record for EPITEX is Gc America Inc..
What is the Primary UDI-DI identifier for EPITEX?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 473005.
What classification code is assigned to this device?
This device is registered under product classification code EHM.
Similar Classification Devices (EHM)
Other Devices by Gc America Inc.
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