Organization name

EUROTEKNIKA

SRN

FR-MF-000004032

Manufacturer status

Active

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• 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.

03700977503852

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

NIPT_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 Ø3.0 - Ø5.0 mm - Naturactis is the device model associated with the Reference/Catalogue number NIPT_00. The surgical kit Ø3.0 - Ø5.0 mm - Naturactis is a fully configured kit composed of various medical devices manufactured by ETK. Its consists of class I medical devices (empty surgical kit Ø3.0 - Ø5.0 mm - Naturactis, universal implant support, direct implant holder, external hex screwdriver) being EC marked as well as Class IIa medical devices (point drill, drill, tap, gauge, paralleling guide, direct implant mandrel, external hex mandrel and extension) 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. The drills, point drills and taps may be reused up to a maximum of 15 times, whereas the empty surgical kit Naturactis, universal implant support, the gauge, paralleling guide, direct implant holder, direct implant mandrel, external hex screwdriver, external hex mandrel, and extension may be reused up to a maximum of 100 times. As the surgical kit Ø3.0 - Ø5.0 mm - 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.