On-X Prosthetic Heart Valve

Dénomination commerciale

On-X Prosthetic Heart Valve

00851788001402

B-00851788001402

Numéro de référence/catalogue

ONXAE-23

GS1

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder (23 mm)

URL des informations complémentaires

https://www.onxlti.com/ifu

Dimensions cliniques

• 23 MU50

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

• P0703020301BILEAFLET MECHANICAL AORTIC VALVES

8 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Ne pas réutiliser
• Ne pas restériliser
• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• RM sûre sous certaines conditions (MR conditional)
• DO NOT use the On-X Prosthetic Heart Valve if the serial number tag does not match the serial number on the container label. DO NOT pass a catheter, surgical instrument, or transvenous pacing lead through the prosthesis as this may cause valvular insufficiency, leaflet damage, leaflet dislodgment, and/or catheter/instrument/lead entrapment. DO NOT re-sterilize the On-X Prosthetic Heart Valve. DO NOT use the On-X Prosthetic Heart Valve if the valve does not rotate easily. DO NOT use the valve for leverage in bending the instrument handle. This could damage the valve and lead to mechanical failure. DO NOT size the sewing ring of the size 19 mm through 25 mm aortic valve to fit within the annulus. Do NOT attempt to reinsert the valve holder into the valve once it has been removed. Aortic and mitral valves use unidirectional valve holders specific to each valve type. Test the leaflet mobility only with the On XLTI On-X leaflet probe or the leaflet probe on the end of the rotator. Use only the On-XLTI On-X rotator to rotate the valve in situ. Use only the correspondingly sized rotator. Use of the wrong size rotator could damage the valve.