PCON2-4-15-12

Organization name

phenox GmbH

SRN

DE-MF-000006524

Manufacturer status

Active

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

• CW011

  For procedural cautions, consult IFU
• 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.
• CW010

  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 theanatomic conditions are not appropriate for endovascular treatment.
• 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 pCONUS."
• CW265

  COBALT

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260123784270

Basic UDI-DI

426012378BifurImplantGK

Reference / catalog number

PCON2-4-15-12

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/bai/

Clinical sizes

• Distal Crown Width 12 mm
• min. vessel diameter 2.5 mm, max. vessel diameter 3.7 mm
• Shaft 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.

• P070402020102NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS

Certificate health across this manufacturer's portfolio.