Organization name

Shape Memory Medical Inc

SRN

US-MF-000008157

Manufacturer status

Active

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

• 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

• The safety and effectiveness of the IMPEDE-FX Rapid Fill 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.

  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

Primary placement in Netherlands; available across 32 countries total.

Trade name

IMPEDE-FX RapidFill

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.

00810041650399

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.

B-00810041650399

Reference / catalog number

IMP-FX-12X5

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://static1.squarespace.com/static/5824e9efc534a57a9599f5a6/t/603552dc6bb8135fe08219e6/1614107363726/IMPEDE-FX+RapidFill+IFU.pdf

Clinical sizes

• 15 MU50
• 12 MU50

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

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

• C0104020209PERIPHERAL VASCULAR SYSTEM TOTAL CHRONIC OCCLUSION DEVICES

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.