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| EMDDB code |
20760
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| Basic UDI-DI |
7611819a00802JU
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| Seadme klass |
Meditsiiniseade
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| Medical Device Nomenclature |
|
| Risk class |
IIa
|
| Appliance |
-
|
| Device name (in Estonian) |
90° Kruvikeeraja
|
| Device name (in English) |
90° Screwdriver
|
| Intended use (is Estonian) |
90° kruvikeeraja on ette nähtud võimaldama intraoraalset ja/või vähem invasiivset juurdepääsu puurimiseks ja kruvi sisestamiseks luusse rakendustes, nagu alalõualuutrauma, ortognaatsed operatsioonid ning rindkereseina trauma ja rekonstruktsioon.
|
| Intended use (in English) |
The 90° Screwdriver is intended to enable an intraoral and/or a less invasive approach for drilling and screw insertion into bone within applications such as mandible trauma, orthognathic surgeries, and chest wall trauma and reconstruction.
|
| Type/model/article number |
03.505.004, 03.505.005
|
| Notified body |
0123
|
| Manufacturer |
Synthes GmbH
|
| Authorised representative |
DePuy Ireland UC
|
| In register from |
07/10/2024
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
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