FILI LISCI Ø2MM L400MM HAP ST 5PZ

Organization name

Mikai s.p.a.

SRN

IT-MF-000030732

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• MR CONDITIONAL

Primary placement in Italy; available across 9 countries total.

Trade name

FILI LISCI Ø2MM L400MM HAP ST 5PZ

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.

08056630553272

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.

805573143IMP00HAPWIRE.S9T

Reference / catalog number

5000341HST5

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

—

Additional information URL

https://www.mikai.us/downloads/

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.

• P09120301KIRSCHNER BONE WIRES

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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