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.

03700977511017

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

UGCT_00

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

Surgical kit CGC iBone/Naturactis is the device model associated with the Reference/Catalogue number UGCT_00 The surgical kit CGC iBone/Naturactis is a fully configured kit composed of various medical devices manufactured by ETK. Its consists of Class I medical devices (empty surgical kit CGC iBone/Naturactis, implant holder tool, ratchet wrench, external hex screwdriver, direct implant holder, implant holder, adapter, implant holder, universal implant support) being EC marked as well as Class IIa medical devices (anchor pin, drill, tap, punch, external hex mandrel, direct implant mandrel, laboratory screw) being EC 0425 marked. 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. The anchor pin, drill, gingival punch, may be reused up to a maximum of 15 times, whereas the implant holder tool,ratchet wrench, external hex screwdriver, external hex mandrel, direct implant holder, direct implant mandrel, direct implant holder, adapter, implant holder, implant holder, universal implant support may be reused up to a maximum of 100 times. As the surgical kit CG iBone/Naturactis contains several medical devices with different maximum numbers of uses, it is not possible to define a single maximum number of uses applicable to the fully configured kit as a whole. This information is therefore considered not applicable. 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.