- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 30, 2022
B-08437021340105TF06 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Osteophoenix SL. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08437021340105TF06(01)08437021340105
European Medical Device Nomenclature — the EU product classification assigned to this device.
P09120604OSTEOSYNTHESIS NAIL-SCREW SYSTEMS3 warnings recorded — scroll inside the panel to see all entries.
Los dispositivos médicos deben ser usados en exclusiva por médicos especializados o capacitados para tal efecto (odontólogos, estomatólogos, cirujanos con experiencia en técnicas de implantología, cirujanos maxilofaciales y ortopédicos o neurocirujanos según el caso específico del que se trate).No pudiendo ser implantados dichos dispositivos por personal ajeno a estas competencias profesionales
PROHIBIDO REUTILIZAR, cuando los productos hayan entrado en contacto con agentes contaminantes, especialmente sangre y saliva, no debe ser reutilizado por no tener una plena seguridad de su eliminación, aunque se limpie y esterilice, dado que la transmisión de estos contaminantes puede provocar enfermedades como SIDA, hepatitis, ETT. Otro motivo para la no reutilización del material serían los posibles daños que pueda haber sufrido la geometría del mismo, puesto que puede tener pequeños defectos y patrones de tensión interna que pueden provocar una rotura temprana. La incorrecta utilización (incluido su segundo uso), puede provocar la falla del dispositivo y, en consecuencia, graves problemas para el paciente como su desprendimiento en boca, ingestión o masticación por accidente de este
ESTERILIZAR, los dispositivos suministrados por Osteophoenix, S.L, se presentan en estado NO estéril. El facultativo deberá esterilizarlo siguiendo las indicaciones que se dan adelante en el presente instructivo
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Apr 2, 2020 | May 26, 2024 |
ES-MF-0000041712084/MDDSterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.