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Single-patient-use instruments and accessories
EUDAMEDFDA UDIClass I (EU MDR)
Ref A0556-00
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic palate expander screw key FDA UDI
- Device Name
- Single-patient-use instruments and accessories EUDAMEDCLASSIC SWIVEL KEY W/PLASTIC HANDLE BLU FDA UDI
- Model / Reference
- A0556-00 EUDAMEDFDA UDI
- Description
- CLASSIC SWIVEL KEY W/PLASTIC HANDLE BLU FDA UDI
Identifiers
- Catalog Number
- A0556-00 FDA UDI
- Primary DI / UDI-DI
- 08033707094999 EUDAMEDFDA UDI
- Basic UDI-DI
- 080337070TDI003VK EUDAMED
- FDA Product Code
- JEX FDA UDI
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthodontic palate expander screw key FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Single-patient-use instruments and accessories by Leone S.p.a. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 080337070TDI003VK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (2)
- EUDAMED 6a7cc9da-8ca8-44f7-a5c3-050db0afd771 61 fields · synced Sep 18, 2026
- FDA UDI b1b08473-73a9-4c4b-831a-0a28364f3284 34 fields · synced May 30, 2026