p48 MW HPC Flow Modulation Device

Organization name

phenox GmbH

SRN

DE-MF-000006524

Manufacturer status

Active

9 warnings recorded — scroll inside the panel to see all entries.

• CW011

  For procedural cautions, consult IFU
• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW026

  EUDAMED did not publish a description for this code.
• CW999

  Contraindication: Patients with an inadequate antiplatelet therapy or insufficient anticoagulant treatment according to standard medical practice before, during, and after the treatment.
• CW999

  Contraindication: Angiography demonstrates the anatomic conditions are not appropriate for endovascular treatment.
• CW999

  Warning: Persons with allergy to Nickel-Titanium-Alloy, Platinum, and other materials listed in this IFU, may suffer an allergic response to the system. Ensure to weigh the benefit of treatment vs. the severity of the allergy risks prior to treatment using this Device in patients

Primary placement in Germany; available across 32 countries total.

Trade name

p48 MW HPC Flow Modulation Device

UDI-DI code

04260123783594

Basic UDI-DI

426012378FlowDiverterSV

Reference / catalog number

P48-MW-HPC-300-15

Issuing entity

GS1

Risk category

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://phenox.net/MDR/FD/

Clinical sizes

• max. vessel diameter 3 mm; min. vessel diameter 2 mm
• effective length in max diameter vessel 15 mm; effective length in min diameter vessel 21.3 mm

• P0704020202PERIPHERAL VASCULAR COATED STENTS

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