Nom de l'organisation

Nova Eye, Inc.

SRN

US-MF-000011341

Statut du fabricant

Actif

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

• Ne pas restériliser

  WARNING: The devices in this kit are intended for single use only. Do not re-sterilize and/or reuse, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing

• Ne pas utiliser si l’emballage est endommagé

  WARNING: Do not use product if the pouch integrity has been compromised.

• Ne pas réutiliser

  WARNING: The devices in this kit are intended for single use only. Do not re-sterilize and/or reuse, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.

• Ne pas utiliser après la date indiquée

  WARNING: Note the product “Use By” date specified on the package. Do not use expired products.

• CONTRAINDICATION: The Canaloplasty Microcatheter is not intended to be used for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in eyes of patients with the following conditions: • Neovascular glaucoma • Angle closure glaucoma • Previous surgery with resultant scarring of Schlemm’s canal

  AUTRE

• PRECAUTION: This device should be used only by physicians trained in ophthalmic surgery. Knowledge of surgical techniques, proper use of the surgical instruments, and post-operative patient management are considerations essential to a successful outcome. PRECAUTION: Do not use a toothed forceps to handle the Canaloplasty Microcatheter, as damage to the device may occur. PRECAUTION: Do not attempt forceful insertion of the Canaloplasty Microcatheter into Schlemm’s canal. The device should be withdrawn immediately if resistance or an obstruction is encountered. PRECAUTION: Avoid kinking or sharp bending of the Canaloplasty Microcatheter. PRECAUTION: Handle the iTrack™ 250A carefully to avoid damaging the device. PRECAUTION: Do not let the viscoelastic dry at the tip of the microcatheter, as this can cause the microcatheter lumen to become occluded. PRECAUTION: Ensure the fiber optic line is not in a path that can be pulled or tripped on. PRECAUTION: When applicable, remove excess viscoelastic from the eye by irrigation and/or aspiration. PRECAUTION: Do not use the product if it appears to be damaged. PRECAUTION: Dispose of the devices, including the microcatheter and ViscoInjector™, in an appropriately labelled, puncture resistant, sharps container after use. PRECAUTION: Do not pull the black fiber optic line or grab onto the blue hub jacket until the assembly has been fully removed from the packaging to avoid damage.

  AUTRE

• WARNING: In the event of microcatheter damage or breakage, recovery of any portion should be performed based upon physician determination of individual condition and appropriate retrieval protocol. WARNING: The fiber optic line and infusion lines must not be pulled as these lines are attached to the back end of the iTrack™ 250A and can be damaged if excessive force is applied. WARNING: Caution: the red light emitted from this instrument is sufficiently low in intensity to pose no hazard to the patient when used correctly in accordance with this instruction for use. Nevertheless, avoid shining light directly from the microcatheter into the pupil of the patient’s eye for periods longer than 5 seconds. It is always good practice to avoid direct staring into the beam of a laser-based instrument.

  AUTRE

Marché principal en Allemagne ; disponible dans 14 pays au total.

Dénomination commerciale

iTrack 250A

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.

00893872001059

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.

0893872001iT-250AKE

Numéro de référence/catalogue

iT-250A

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 RDM

Les classes de risque du RDM 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 IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Nova Eye Canaloplasty Microcatheter Kit (iTrack™ 250A) consists of an illuminated, flexible microcatheter and Ophthalmic Viscoinjector™. The Canaloplasty Microcatheter is a flexible microcatheter design for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The ophthalmic ViscoInjector™ is a manually operated device for precision delivery of small amounts of viscous fluid such as sterile viscoelastic solution in a cartridge. The device are provided sterile and are intended for single use. The iTrack™ 250A is designed to work with the Nova Eye iLumin™ Fiberoptic Illuminator.

URL des informations complémentaires

https://res.nova-eye.com/ifu/

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.

• Q0299OPHTHALMIC DEVICES - OTHER

• Dispositifs médicaux de Classe IIa dans EUDAMED

• 28620238771-00Complété
  Système de management de la qualitéOrganisme notifié: Intertek Medical Notified Body AB (2862)Expire: 26 oct. 2030

Santé des certificats sur le portefeuille de ce fabricant.