PEGASUS-HPC-450-20

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, such as severe vessel tortuosity or severe stenosis.
• CW999

  "Warning: Persons with known hypersensitivity to Nickel-Titanium materials or the materials listed in chapter “Materials to come in contact with the patient during the intervention” may suffer an allergic reaction to the pEGASUS (HPC)"

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04260123784775

Basic UDI-DI

426012378NeuroStentTE

Reference / catalog number

PEGASUS-HPC-450-20

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/nest/

Clinical sizes

• Stent length 20 mm
• max. vessel diameter 4.5 mm; min. vessel diameter 3.5 mm

• P0704020202PERIPHERAL VASCULAR COATED STENTS

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