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50 Left Silktoe Trial Sizer (Red)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BRDNPTEST50L
Identity
- Trade Name
- 50 Left Silktoe Trial Sizer (Red) EUDAMEDSILKTOE INSTRUMENT FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Strumenti chirurgici in silicone accessori all'impianto dei dispositivi Silktoe EUDAMED
- Model / Reference
- BRDNPTEST50L EUDAMED50 Left Silktoe Trial Sizer (Red) FDA UDI
Identifiers
- Catalog Number
- BRDNPTEST50L FDA UDI
- Primary DI / UDI-DI
- 08057717559668 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT09B6CD EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- V06010199 ORTHOPAEDIC PROSTHESES TESTING DEVICES - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
50 Left Silktoe Trial Sizer (Red) by BRM Extremities S.r.l. — Class IIa — 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 | 805771755FT09B6CD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BRM Extremities S.r.l.
- EUDAMED SRN
- IT-MF-000016087
Sources (2)
- EUDAMED 19bf7f34-4848-464a-ad40-bdc13c31e2a0 61 fields · synced Jul 24, 2026
- FDA UDI 87151701-453a-4347-9f69-06e58220d03a 35 fields · synced May 27, 2026