gudid
Primary ID: 5038
SecureFoam (UDI 5038)
Manufactured by Bionix, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SecureFoam - Primary ID 5038
Device Regulatory Overview
The SecureFoam (Model/Catalog Number: 5038) is a medical device manufactured by Bionix, LLC. This product is indexed under FDA Product Code / Category Classification IYE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 5038
- Product Code / EMDN
- IYE
- Device Name
- SecureFoam, Large, Component A
- Database Sync Date
- 2026-08-09 09:04:11
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 SecureFoam?
The registered manufacturer of record for SecureFoam is Bionix, LLC.
What is the Primary UDI-DI identifier for SecureFoam?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5038.
What classification code is assigned to this device?
This device is registered under product classification code IYE.
Similar Classification Devices (IYE)
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