Organization name

Brainlab SE

SRN

DE-MF-000006183

Manufacturer status

Active

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

Primary placement in Germany; available across 29 countries total.

Trade name

Drill Guide Trocar Insert (2.6 mm)

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.

04056481145071

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.

4056481DrillGuideTubeCW

Reference / catalog number

51839-95

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2.6 mm

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

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

• Z12011480SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.