gudid
Primary ID: BGS-8C-001-AGL
DirectCell Advanced Bone Grafting System (UDI BGS-8C-001-AGL)
Manufactured by Biogennix, LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DirectCell Advanced Bone Grafting System - Primary ID BGS-8C-001-AGL
Device Regulatory Overview
The DirectCell Advanced Bone Grafting System (Model/Catalog Number: BGS-8C-001-AGL) is a medical device manufactured by Biogennix, LLC. This product is indexed under FDA Product Code / Category Classification KNW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BGS-8C-001-AGL
- Product Code / EMDN
- KNW
- Device Name
- Kit Contains: (1) 001-AGL, 1.5cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit
- Database Sync Date
- 2026-08-09 09:43:41
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 DirectCell Advanced Bone Grafting System?
The registered manufacturer of record for DirectCell Advanced Bone Grafting System is Biogennix, LLC.
What is the Primary UDI-DI identifier for DirectCell Advanced Bone Grafting System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BGS-8C-001-AGL.
What classification code is assigned to this device?
This device is registered under product classification code KNW.
Similar Classification Devices (KNW)
Other Devices by Biogennix, LLC
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