Organization name

Mirion Technologies (Capintec), Inc.

SRN

US-MF-000000770

Manufacturer status

Active

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

Primary placement in Austria; available across 32 countries total.

Trade name

Bar Phantom, Rectangular

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.

00859942006430

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.

08599420061044Y

Reference / catalog number

243-935

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

The Bar Phantom is a Radionuclide Test Pattern device used to evaluate the performance characteristic of a nuclear medicine gamma camera. It determines the gamma camera’s intrinsic resolution, collimator spatial resolution, field size, and linearity.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• Z11020280INTEGRATED CT/GAMMA CAMERA SYSTEMS - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED