Identity
- Trade Name
- Silktoe Handle Sliding Unit EUDAMEDSILKTOE INSTRUMENT FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Dispositivi non invasivi di classe I accessori all’impianto dei dispositivi Silktoe EUDAMED
- Model / Reference
- BRDNPTHANDSU EUDAMEDSilktoe Handle Sliding Unit FDA UDI
Identifiers
- Catalog Number
- BRDNPTHANDSU FDA UDI
- Primary DI / UDI-DI
- 08057717551273 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT07C2BW EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical mallet 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
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
Moist Heat or Steam Sterilization FDA UDI
Silktoe Handle Sliding Unit 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 | 805771755FT07C2BW | 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 37cdf6cf-3f3f-4678-b04e-75975d136a86 61 fields · synced Jun 18, 2026
- FDA UDI a97295d0-b0bf-4465-8168-6ff4c6bbdcf8 36 fields · synced May 30, 2026