Organization name

Arthrex Inc.

SRN

US-MF-000019271

Manufacturer status

Active

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

• Consult instructions for use
• P103 – Read label before use.

Primary placement in Netherlands; available across 27 countries total.

Trade name

Arthrex

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.

00888867421851

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.

0888867TibNailSys0000002H

Reference / catalog number

AR-9098-13-345

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

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

Status

On the market

Quantity

1

Additional product description

Tibial Nail, 13.0 mm x 34.5 cm

Additional information URL

https://www.arthrex.com/eDFU

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.

• P09120201INTRAMEDULLARY NAILS

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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