Organization name

EUROTEKNIKA

SRN

FR-MF-000004032

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  https://ifu.lyraetk.com

Primary placement in France; available across 21 countries total.

Trade name

not provided

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.

03700977505597

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.

37009775foretE5

Reference / catalog number

KCIG

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Kit iBone G is the device model associated with the Reference/Catalogue number KCIG. The kit iBone G is a fully configured kit composed of various medical devices manufactured by ETK. Its consists of Class I medical devices (direct implant holder, paralleling guide) being EC marked as well as Class IIa medical devices (direct implant mandrel) being EC 0425 marked, assembled and marketed exclusively as a kit. The components contained in this kit are semi-finished products not intended for individual sale. However, they have the same technical characteristics, specifications, and intended purpose as the equivalent finished medical devices marketed separately as standalone products. The medical devices contained in the kit are non-sterile and reusable. All the medical devices in this kit (direct implant holder, paralleling guide, direct implant mandrel) as well as the empty kit itself, can be reused up to a maximum of 100 times. Therefore, the maximum number of uses (corresponding to the sterilization cycles) applicable to the complete prosthetic kit is 100 uses. The maximum storage temperature for the fully configured kit is 30 °C.

Additional information URL

https://ifu.lyraetk.com/

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.

• Q010399SURGICAL DENTAL DEVICES - OTHER

• Class IIa medical devices in EUDAMED

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