← Back to catalogue
TOOL PRO Ø 7.0 x 105 FULL THREAD
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SOS170105TSRef SOS170105TU
Identity
- Trade Name
- TOOL PRO Ø 7.0 x 105 FULL THREAD EUDAMEDTOOL PRO Ø 7.0 x 105 FULL THREAD – NON STERILE EUDAMEDBRM TOOL PRO Titanium Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Viti per osteosintesi EUDAMED
- Model / Reference
- SOS170105TS EUDAMEDSOS170105TU EUDAMED7.0 x 105 mm - Full thread - Sterile FDA UDI
Identifiers
- Catalog Number
- SOS170105TS FDA UDI
- Primary DI / UDI-DI
- 08057717555820 EUDAMEDFDA UDI08057717558227 EUDAMED
- Basic UDI-DI
- 805771755FT05FZ EUDAMED
- 510(k) Number
- K203773 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120603 CANNULATED SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 7 Millimeter FDA UDILength — 105 Millimeter FDA UDI
TOOL PRO Ø 7.0 x 105 FULL THREAD by BRM Extremities S.r.l. — Class IIb — 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 | 805771755FT05FZ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BRM Extremities S.r.l.
- EUDAMED SRN
- IT-MF-000016087
Sources (3)
- EUDAMED 99ced521-bbff-4a5f-a060-1e2e2a6f07e1 61 fields · synced Jul 18, 2026
- FDA UDI 262dabee-c42e-4cc3-83b2-37479270a0b9 37 fields · synced May 30, 2026
- EUDAMED 2b429a64-e60e-44c3-abda-6af7a0e41255 61 fields · synced Jul 18, 2026