Organization name

SYNERGIE INGENIERIE MEDICALE

SRN

FR-MF-000001635

Manufacturer status

Active

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• The Percutaneous vertebroplasty must be performed by Medical Professionals with an appropriate expertise in the method, in an institutional environment with the equipment required to ensure the normal development of the procedure and the access to an immediate treatment in case of any undesired reaction in the patient. The percutaneous vertebroplasty must be performed under real time radioscopic monitoring in order to control the cement distribution inside the vertebral body. The lack of adequate control can entail serious and even irreversible lesions in the patient. (fractures, migration of bone fragments, cement leakage into vascular, neurologic, and other structures). It is recommended that the surgeon should wear eye protection due to the risk of splashes onto the face and eyes. Note: These instructions are not meant to define or suggest any particular surgical technique. The surgeon is responsible for the choice of the appropriate procedure relative to the use of this sanitary product.

  OTHER

Primary placement in France; available across 32 countries total.

Trade name

Biofix VTP Integral System APV

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

03700448201225

Basic UDI-DI

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.

B-03700448201225

Reference / catalog number

884027

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The complete cement application system for vertebroplasty is used for the application of any cement specifically designed for vertebroplasty.

Additional information URL

https://www.synimed.com/

Clinical sizes

• Ø2.4 x 100mm

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A019011INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.