Identity
- Trade Name
- Silktoe 20-30 Cutting Guide EUDAMEDBRM SILKTOE INSTRUMENT FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- Strumenti chirurgici riutilizzabili accessori all'impianto dei dispositivi Silktoe EUDAMED
- Model / Reference
- BRDNPTCG2030 EUDAMEDSilktoe 20-30 Cutting Guide FDA UDI
Identifiers
- Catalog Number
- BRDNPTCG2030 FDA UDI
- Primary DI / UDI-DI
- 08057717559576 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT08C2C3 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Osteotomy guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Silktoe 20-30 Cutting Guide by BRM Extremities S.r.l. — 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 | 805771755FT08C2C3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BRM Extremities S.r.l.
- EUDAMED SRN
- IT-MF-000016087
Sources (2)
- EUDAMED 66a9a2b5-7322-4710-92f0-be6ba76dd711 61 fields · synced Jun 19, 2026
- FDA UDI b17b301a-6016-406c-924e-511a94a1e3a3 35 fields · synced May 29, 2026