Organization name

Inion Oy

SRN

FI-MF-000000646

Manufacturer status

Active

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

• Do not resterilize
• Do not use if package is damaged
• Do not re-use
• Consult instructions for use
• Do not use past indicated date
• MR SAFE

Primary placement in Finland; available across 32 countries total.

Trade name

Inion CompressOn™ Screw

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.

06438408008733

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-06438408008733

Reference / catalog number

OSH-5050

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

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

Status

On the market

Quantity

1

Additional product description

5.0 x 50 mm screw

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.

• P09120606OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS

• Class III medical devices in EUDAMED

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