GMS 805

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.

• CW001

  For single use only. Do not reuse, reprocess or re-sterilize the LiNA Versascope™ Sheath. 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.
• CW007

  The LiNA Versascope™ Sheath is supplied sterile using an ethylene oxide. 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
• CW009

  For single use only. Do not reuse, reprocess or re-sterilize the LiNA Versascope™ Sheath. 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.
• 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.

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

05708265013531

Basic UDI-DI

57082651023-1ZH

Numéro de référence/catalogue

GMS 805

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

The LiNA Versascope™ Sheath GMS805 is a curved access sheath of small diameter intended to be used only with the compatible hysteroscope AlphaScope Hysteroscope (GMS40A). The LiNA Versascope Sheath is a single use, sterile device comprised of both metal and plastic components. The device incorporates a channel for insufflation accessed through the attached tubing and connector. Also incorporated is an expandable channel for insertion of hysteroscopic instruments which provides continuous flow where fluids media is utilized for distention. A rational collar provides convenient viewing perspective of the uterine cavity.

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.