Synimed V Gun

Dénomination commerciale

Synimed V Gun

03700448214430

B-03700448214430

Numéro de référence/catalogue

880582

GS1

Classe I

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Reusable injection gun for use exclusively with the components of the Synimix V Vacuum Mixer and Application System (and other brands manufactured by Synimed S.A.R.L) for the administration of bone cement.

URL des informations complémentaires

https://www.synimed.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• L091105CEMENTATION INSTRUMENTS, REUSABLE

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• •Under no circumstances should it be used with products from other manufacturers. •The instructions provided are intended as a guide for the reprocessing of the Synimed V 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 V gun, the person must comply with personal hygiene and safety standards, as well as use appropriate protective equipment and supplies. •The used Synimed V gun is considered a biological hazard; therefore, healthcare institutions must ensure that transport and handling procedures comply with local regulations and guidelines. •The Synimed V gun must be carefully inspected before each use to ensure it is in working order. •The Synimed V gun must be cleaned separately from the tray to achieve adequate cleaning results. The tray was designed as an organizational aid in preparation for sterilization, storage and surgical use. It is not designed to be cleaned whilst fully assembled.

  AUTRE