Gynecology Procedure Pack-Gyna I

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

60644- Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

Model / Reference

7702

Primary DI / UDI-DI

08698904677026

Basic UDI-DI

86989046PPACK-GYNEQ4

EMDN Code

V0599 Clinical procedures kits not included in other classes - other

Device Class

Class IIa

Medical Purpose

Performed within the scope of Gynaecological Surgery; • Removal of the uterus • Urinary incontinence surgery • Vaginal hysterectomy • Laparoscopic hysterectomy • Ovarian cysts and adnexal mass surgery • Vaginal repair • Abdominal hysterectomy etc. In addition to the preparation of the working environment with protective covers and clothing that help maintain cleanliness and limit the risk of contamination during surgical operations, in order to support aseptic practices during the preparation of the operating theatre and to increase the efficiency of the operating theatre; It is a set of surgical trays or sets created by collecting different disposable medical devices and instruments required for professional use in the relevant surgical procedure in a single package ready for presentation to the operating theatre.

EUDAMED SRN

TR-PR-000037421

• Artroscopy Pack (Drape Set)

  Class I

  CE/MDR

• Dsa Angio Drape Pack

  Class I

  CE/MDR

• Dressing Pack II

  Class IIa

  CE/MDR

• Opthalmic Drape Set (Drape Set)

  Class I

  CE/MDR

• Spinal- Orthopaedic Drape Set

  Class I

  CE/MDR

• Local Operation Drape Pack

  Class I

  CE/MDR

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