CirFIX Cranial bone fixation system: Burr Hole Cover (UDI 9905.0014.11S)
Manufactured by OSSAWARE BIOTECH CO., LTD.
Device Regulatory Overview
The CirFIX Cranial bone fixation system: Burr Hole Cover (Model/Catalog Number: 9905.0014.11S) is a medical device manufactured by OSSAWARE BIOTECH CO., LTD.. This product is indexed under FDA Product Code / Category Classification GXR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 9905.0014.11S
- Product Code / EMDN
- GXR
- Device Name
- CUSMED CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
- Database Sync Date
- 2026-08-09 09:15:29
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 CirFIX Cranial bone fixation system: Burr Hole Cover?
The registered manufacturer of record for CirFIX Cranial bone fixation system: Burr Hole Cover is OSSAWARE BIOTECH CO., LTD..
What is the Primary UDI-DI identifier for CirFIX Cranial bone fixation system: Burr Hole Cover?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 9905.0014.11S.
What classification code is assigned to this device?
This device is registered under product classification code GXR.
Similar Classification Devices (GXR)
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