PEGASUS-HPC-450-15

Organization name

phenox GmbH

SRN

DE-MF-000006524

Manufacturer status

Active

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

• 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)"
• 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.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04260123784768

Basic UDI-DI

426012378NeuroStentTE

Reference / catalog number

PEGASUS-HPC-450-15

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/nest/

Clinical sizes

• max. vessel diameter 4.5 mm; min. vessel diameter 3.5 mm
• Stent length 15 mm

• P0704020202PERIPHERAL VASCULAR COATED STENTS

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