gudid
Primary ID: FC050400
Cranial COVER 10-12 mm (UDI FC050400)
Manufactured by NEOS SURGERY SL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Cranial COVER 10-12 mm - Primary ID FC050400
Device Regulatory Overview
The Cranial COVER 10-12 mm (Model/Catalog Number: FC050400) is a medical device manufactured by NEOS SURGERY SL. This product is indexed under FDA Product Code / Category Classification GXR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FC050400
- Product Code / EMDN
- GXR
- Device Name
- Burr Hole Cover
- Database Sync Date
- 2026-08-09 09:41:12
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 Cranial COVER 10-12 mm?
The registered manufacturer of record for Cranial COVER 10-12 mm is NEOS SURGERY SL.
What is the Primary UDI-DI identifier for Cranial COVER 10-12 mm?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FC050400.
What classification code is assigned to this device?
This device is registered under product classification code GXR.
Similar Classification Devices (GXR)
Other Devices by NEOS SURGERY SL
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