gudid
Primary ID: 33516
FusionMAX (UDI 33516)
Manufactured by SURGIX MEDICAL LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FusionMAX - Primary ID 33516
Device Regulatory Overview
The FusionMAX (Model/Catalog Number: 33516) is a medical device manufactured by SURGIX MEDICAL LLC. This product is indexed under FDA Product Code / Category Classification JEA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 33516
- Product Code / EMDN
- JEA
- Device Name
- FlexFrame- Patient supoort device. Designed to support and position torso in prone position. Two carbon fiber arc plates with removable pads fit into base that is attached to surgical table top. Height adjustable with crank handle.
- Database Sync Date
- 2026-08-09 09:07:53
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 FusionMAX?
The registered manufacturer of record for FusionMAX is SURGIX MEDICAL LLC.
What is the Primary UDI-DI identifier for FusionMAX?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 33516.
What classification code is assigned to this device?
This device is registered under product classification code JEA.
Similar Classification Devices (JEA)
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