Silktoe 35 Metatarsal Grommet Impactor
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Silktoe 35 Metatarsal Grommet Impactor EUDAMEDSILKTOE INSTRUMENT FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Strumenti chirurgici riutilizzabili accessori all'impianto dei dispositivi Silktoe EUDAMED
- Model / Reference
- BRDNPTI3535P EUDAMED35 SILKTOE METATARSAL GROMMETS IMPACTOR FDA UDI
Identifiers
- Catalog Number
- BRDNPTI3535P FDA UDI
- Primary DI / UDI-DI
- 08057717559705 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT08C2C3 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic implant impactor, reusable
Silktoe 35 Metatarsal Grommet Impactor by BRM Extremities S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 7c5d70d4-fb0d-4dcb-a1bc-966b3fd3e174 61 fields · synced Jun 18, 2026
- FDA UDI ab4f7f18-1e0f-40bb-a0a1-c24f175a3e34 36 fields · synced May 30, 2026