Organization name

Shape Memory Medical Inc

SRN

US-MF-000008157

Manufacturer status

Active

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

• The safety and effectiveness of the IMPEDE-FX Embolization Plug has not been established for cardiac uses (e.g., cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closure) or neurologic uses.

  OTHER

• Inspect the package and system prior to use. Do not use if the sterile package is open or damaged or if the system is damaged.v

  OTHER

• Device is intended for single-use only. Do not attempt to re-process, re-sterilize, clean, or re-use the device. Improper sterilization and re-use can cause malfunction to the device and injury to the patient.

  OTHER

• Do not use a power injection syringe to inject contrast solution through the device.

  OTHER

• Do not use after the “Use-by” date specified on the package.

  OTHER

• Only physicians who have received appropriate training and who are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with embolization and interventional procedures should use this device.

  OTHER

• Please note care in specific populations: pregnancy - care should be taken to minimize radiation exposure to the mother and fetus, and nursing mothers - there has been no quantitative assessment of the presence of leachables in breast milk.

  OTHER

Primary placement in Italy; available across 12 countries total.

Trade name

IMPEDE-FX Embolization Plug, 12mm

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00810041650054

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

081004165IMP8Z

Reference / catalog number

IMP-FX-12

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 12 MU50

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

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

• C010402020399EMBOLISATION DEVICES - OTHER

• Class III medical devices in EUDAMED

• 1000275865Issued
  Technical documentationNotified body: DQS Medizinprodukte GmbH (0297)Expiry: Dec 18, 2030
• 1000156813Issued
  Quality management systemNotified body: DQS Medizinprodukte GmbH (0297)Expiry: Dec 18, 2030

Certificate health across this manufacturer's portfolio.