Organization name

CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions

SRN

US-MF-000008229

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

omniTRAX™ Active Patient Tracker Starter Kit

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.

00841436111768

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.

0841436101TD103C2NR

Reference / catalog number

610-1299

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Non-sterile markers (5) for use with MR and US enviroments, reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™, drive BAY 2, trakstar™ or trakSTAR 2 trackers

Additional information URL

https://www.civco.com/

Clinical sizes

• 1.95 MU28
• 7 MU28

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

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

• Z11039099VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER

• Class I medical devices in EUDAMED

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