EndoClot®

Nom de l'organisation

EndoClot Plus, Inc.

SRN

US-MF-000003502

Statut du fabricant

Actif

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• CONTRAINDICATIONS EndoClot® PHS is contraindicated in patients who are sensitive to starch or starch-derived materials. It is also contraindicated in patients who have gastrointestinal fistulas, are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment. Do not use EndoClot® PHS for controlling surgical bleeding, it is intended for use only in the gastrointestinal tract. Do not inject AMP® particles into blood vessels: extensive intravascular coagulation may occur. Do not inject AMP® particles into the bile duct or pancreatic duct. Do not inject AMP® particles into the bladder or ureteral lumen. Do not use AMP® particles for controlling post-partum bleeding or menorrhagia. Do not use on patients suspected to have a bowel obstruction or ileus. Do not use the device in the vicinity of gastrointestinal anastomoses or gastrointestinal orifices such as gastrointestinal diverticula, the pancreatic duct, and the appendiceal orifice.

  AUTRE

• WARNING EndoClot® PHS is not intended as a substitute for good surgical practice, and in particular, the proper use of conventional procedures for hemostasis. Combined use of EndoClot® PHS with other topical hemostatic agents has not been studied in controlled clinical trials. Patients with gastrointestinal bleeding that are on antithrombotic medication or have coagulopathy may be at an increased risk of rebleeding. Follow the relevant clinical guidelines for management of antithrombotic agents for endoscopic procedures. EndoClot® PHS is designed for single use only. Attempts to reprocess, resterilize or reuse may lead to device failure and/or transmission of disease. Ensure gastrointestinal lumen is not distended when EndoClot® PHS is used in the gastrointestinal tract as excessive luminal pressure may be generated by the air source to cause bowel rupture and air embolism. Use this device immediately after the package has been opened. Do not use if the package is opened or damaged when received. Do not use this device for any purpose other than stated intended use. If any serious incidents related to the device occur, please report to the manufacturer and the local competent authority.

  AUTRE

• PRECAUTIONS EndoClot® PHS is not recommended as a primary treatment for coagulation disorders. EndoClot® PHS is intended to be used in a dry state. Contact with fluids prior to application will result in the loss of hemostatic efficacy. As a granular material, unintentional exposure to the powder may cause potential irritation to the skin, eyes and lungs. In the event of unintended exposure to the powder refer to the following First Aid measures: -Skin: Wash with soap and water until clean. -Eyes: Flush with water until irritation ceases. -Inhalation: Move to area free from powder. If symptoms of irritation persist, contact physician. Inhalation may aggravate existing respiratory illness. All endoscopic hemostatic therapies, including EndoClot® PHS, have an associated risk of rebleeding. particularly in situations where the cause of bleeding is an unresolved underlying disease. After hemostasis has been achieved, monitor patients for rebleeding per the relevant Clinical Guidelines. Although not seen in clinical practice, there remains a theoretical risk of aspiration of AMP® particles resulting in respiratory complications. It is prudent to restrict the use of EndoClot® PHS to 5cm below the UES.

  AUTRE

Marché principal en Turquie ; disponible dans 12 pays au total.

Dénomination commerciale

EndoClot®

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

00856886003044

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

B-00856886003044

Numéro de référence/catalogue

EPK2302

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque MDR

Les classes de risque du MDR classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS) is a sterilized single use medical device that is composed of absorbable modified polymer (AMP®) particles and an applicator with a tube connecting to a clean external air source. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch. The device contains no human or animal components. The particles are delivered through a catheter inserted through the working channel of an endoscope which provides access to the bleeding site.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 2–2.2 MU24

• 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.

• M040501POLYSACCHARIDE HAEMOSTATIC DRESSINGS

• Dispositifs médicaux de Classe III dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.