gudid
Primary ID: SPE-US 00 59-N
ROMEO2-Instruments Degen (UDI SPE-US 00 59-N)
Manufactured by SpineArt SA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ROMEO2-Instruments Degen - Primary ID SPE-US 00 59-N
Device Regulatory Overview
The ROMEO2-Instruments Degen (Model/Catalog Number: SPE-US 00 59-N) is a medical device manufactured by SpineArt SA. This product is indexed under FDA Product Code / Category Classification HWN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SPE-US 00 59-N
- Product Code / EMDN
- HWN
- Device Name
- HOOK TIP - LEFT
- Database Sync Date
- 2026-08-09 09:07:23
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 ROMEO2-Instruments Degen?
The registered manufacturer of record for ROMEO2-Instruments Degen is SpineArt SA.
What is the Primary UDI-DI identifier for ROMEO2-Instruments Degen?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SPE-US 00 59-N.
What classification code is assigned to this device?
This device is registered under product classification code HWN.
Similar Classification Devices (HWN)
Other Devices by SpineArt SA
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