gudid
Primary ID: SM-0089
GEN2 (UDI SM-0089)
Manufactured by SURGIX MEDICAL LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GEN2 - Primary ID SM-0089
Device Regulatory Overview
The GEN2 (Model/Catalog Number: SM-0089) is a medical device manufactured by SURGIX MEDICAL LLC. This product is indexed under FDA Product Code / Category Classification LXH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SM-0089
- Product Code / EMDN
- LXH
- Device Name
- 14mm Distraction Screw, 5 per box
- Database Sync Date
- 2026-08-09 09:03:56
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 GEN2?
The registered manufacturer of record for GEN2 is SURGIX MEDICAL LLC.
What is the Primary UDI-DI identifier for GEN2?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SM-0089.
What classification code is assigned to this device?
This device is registered under product classification code LXH.
Similar Classification Devices (LXH)
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