gudid
Primary ID: 6195-1-001
Simplex HV with Gentamicin (UDI 6195-1-001)
Manufactured by OSARTIS GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Simplex HV with Gentamicin - Primary ID 6195-1-001
Device Regulatory Overview
The Simplex HV with Gentamicin (Model/Catalog Number: 6195-1-001) is a medical device manufactured by OSARTIS GmbH. This product is indexed under FDA Product Code / Category Classification MBB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 6195-1-001
- Product Code / EMDN
- MBB
- Device Name
- Simplex HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
- Database Sync Date
- 2026-08-09 09:17:36
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 Simplex HV with Gentamicin?
The registered manufacturer of record for Simplex HV with Gentamicin is OSARTIS GmbH.
What is the Primary UDI-DI identifier for Simplex HV with Gentamicin?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 6195-1-001.
What classification code is assigned to this device?
This device is registered under product classification code MBB.
Similar Classification Devices (MBB)
Other Devices by OSARTIS GmbH
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