PEGASUS-350-15-HPC

Organization name

femtos GmbH

SRN

DE-MF-000005499

Manufacturer status

Active

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

• CW011

  For procedural cautions consult instructions for use
• 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: Treatment is contraindicated in patients in whom antiplatelet and/or anticoagulation therapy is contraindicated or antiplatelet therapy did not start in a timely manner prior to treatment.
• CW999

  Contraindication: Treatment is contraindicated in patients in whom angiography demonstrates the anatomy is not appropriate for endovascular treatment, such as severe vessel tortuosity or stenosis.
• CW999

  Labelling: The product is made of a nickel-titanium alloy (NiTi).

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04270000054150

Basic UDI-DI

B-04270000054150

Reference / catalog number

PEGASUS-350-15-HPC

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://phenox.net/international/pegasus-stent-system/

Clinical sizes

• max. vessel diameter 3.5 mm, min. vessel diameter 2.5 mm
• Stent length 15 mm

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P0704020202PERIPHERAL VASCULAR COATED STENTS