Synimed Gun

Trade name

Synimed Gun

03700448215789

B-03700448215789

Reference / catalog number

880593

GS1

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Reusable gun for use with Seringue Synicem gun. The Synimed GUN has been designed exclusively for use with the components of the Synicem GUN disposable cement application system. This metal gun is designed to drive the plunger of the Synicem GUN syringe, thereby applying the cement to the femoral cavity during a hip replacement operation. The Synimed GUN has a uniform colour and surface finish, free from burrs, imperfections or visible impurities.

Additional information URL

https://www.synimed.com/

Clinical sizes

No clinical sizes registered for this device.

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

• L091105CEMENTATION INSTRUMENTS, REUSABLE

1 warning recorded — scroll inside the panel to see all entries.

• •It must not be used under any circumstances with products from other manufacturers. •The instructions provided are intended as a guide for the reprocessing of the Synimed GUN and have been validated by the manufacturer. It is the responsibility of the healthcare institution to ensure that reprocessing is carried out using the appropriate equipment, materials and competent staff in an area designated for such reprocessing. This includes the handling of the devices during transport, reprocessing and storage prior to use. •Before, during and after the reprocessing of the Synimed GUN, the person must comply with personal hygiene and safety standards, as well as use appropriate protective equipment and supplies. •The used Synimed GUN is considered a biological hazard; therefore, healthcare institutions must ensure that transport and handling procedures comply with local regulations and guidelines. •The Synimed GUN must be carefully inspected before each use to ensure it is in working order. •The Synimed GUN must be cleaned separately from the tray to achieve adequate cleaning results. The tray is designed as an organizational aid in preparation for sterilization, storage and surgical use. It is not designed to be cleaned whilst fully assembled.

  OTHER