PRES-5-40

Organization name

phenox GmbH

SRN

DE-MF-000006524

Manufacturer status

Active

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

• 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.
• CW011

  For procedural cautions, consult IFU
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with pre-existing hemorrhage in the brain tissue supplied by the target vessel
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with established infarction in the brain tissue supplied by the target vessel
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with known sensitivity to nickel-titanium
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with stenosis and/or previously implanted stent proximal to the thrombus site that may preclude safe recovery of the device
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with tortuous intracranial vessels precluding safe retraction of the device
• CW265

  COBALT
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with angiographic evidence of carotid dissection
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with vessels with a diameter smaller than the lower limit as indicated in the IFU labeling

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260123784089

Basic UDI-DI

426012378ThrombectomyF6

Reference / catalog number

PRES-5-40

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/international/mdr/ts

Clinical sizes

• Shaft diameter 5 mm; min. vessel diameter 2 mm
• usable length 45 mm

• C010402020702MECHANICAL PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS

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

Certificate health across this manufacturer's portfolio.