P03-001-001-A1

Organization name

ASPIVIX SA

SRN

CH-MF-000026572

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Contraindications: Cervix diameter smaller than 26 mm (1.02 in). Severe vaginal bleeding. Visible, symptomatic cervical or vaginal infections. Invasive cervical cancer (cervical carcinoma). Previous cervical surgery, resulting in a cervix deformation (such as Conization/Loop Electro-surgical Excision). Large ectopy or scar tissue, for which it is not possible to find a native tissue suitable for Carevix™ application. Any cervix abnormalities that do not permit a good adaptation of the Suction Head to the cervix, such as, but not limited to, Mullerian anomalies with two cervices, Nabothian cyst, Cervical myomas, Cervical condylomas, Squamous intra-epithelial lesion (Cervical dysplasia), Cervical endometriosis, Cervical tears, Cervical polyp. Hypersensitivity to device materials such as Polycarbonate/Polyester alloy, MABS, and thermoplastic elastomer. Warnings: For single patient use only. CarevixTM may be used multiple times with the same patient during the same gynecological procedure. Inspect the product before use CarevixTM is intended for continuous use for less than 60 minutes. Do not reuse, reprocess, or re-sterilize CarevixTM. It compromises the structural integrity of the device and/or leads to device failure which, in turn, may result in patient injury. Do not attempt to tamper with CarevixTM. Any tampering with CarevixTM may compromise its safety and performance. 5.WARNINGS- Do not use if sterile barrier is damaged or open.- Do not use if the product is damaged or expired.- Do not use the product if dropped on the floor after the sterile barrier has been removed. Precautions: Store in a cool and dry place. Keep away from sunlight, rain, and extreme temperatures. Store at temperature range: 7°C (45°F) – 29°C (85°F) and within relative humidity range: 30% - 60%. Vacuum mechanism is pressure sensitive: Do not use at an altitude higher than 1500 m (4921.26 ft) for optimal suction efficiency.

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

not provided

UDI-DI code

07649995423079

Basic UDI-DI

7649995423P03MH

Reference / catalog number

P03-001-001-A1

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Suction Cervical Stabilizer

Additional information URL

https://eifu.aspivix.com/

Clinical sizes

No clinical sizes registered for this device.

• Z12080299GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.