GMS 702

Nom de l'organisation

LiNA Medical ApS

SRN

DK-MF-000003706

Statut du fabricant

Actif

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

• CW007

  The LiNA Versascope™ Outflow Cannula is supplied sterile using an ethylene oxide sterilization. Carefully inspect the packaging for any damage prior to use. Do not attempt to use the device if product sterile barrier or its packaging is damaged
• CW011

  Hysteroscopy procedures performed during pregnancy can result in miscarriage. Suspicion of pregnancy should suggest a pregnancy test prior to the performance of diagnostic hysteroscopy.
• CW001

  For single use only. Do not reuse, reprocess or re-sterilize the LiNA Versascope™ Outflow Cannula. Any reprocessing may impede the functions of the device. Reusing single use devices may also increase the risk of cross contamination which may lead to infection or transmission of bloodborne pathogens to patients and users. Attempts to clean the device results in risk of device malfunction.
• CW009

  For single use only. Do not reuse, reprocess or re-sterilize the LiNA Versascope™ Outflow Cannula. Any reprocessing may impede the functions of the device. Reusing single use devices may also increase the risk of cross contamination which may lead to infection or transmission of bloodborne pathogens to patients and users. Attempts to clean the device results in risk of device malfunction.
• CW032

  Do not use past expiration date.

Marché principal en Danemark ; disponible dans 7 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05708265013562

Basic UDI-DI

57082651023-1APL

Numéro de référence/catalogue

GMS 702

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

LiNA Versascope™ Outflow Cannula GMS720 is a flexible, small diameter cannula intended to be used only with the LiNA Versascope™ Sheath. The LiNA Versascope™ Outflow Cannula is a single use, sterile device comprised of plastic components. The LiNA Versascope™ Outflow Cannula opens the expandable channel of the LiNA Versascope™ Sheath to provide for continuous flow, where fluids media is utilized for distension.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• Z12020799GENITOURINARY ENDOSCOPY INSTRUMENTS – OTHER

Santé des certificats sur le portefeuille de ce fabricant.