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TOOL PRO Ø 7.0 x 90 SHORT THREAD – STERILE
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SOS170090CSRef SOS170090C
Identity
- Trade Name
- TOOL PRO Ø 7.0 x 90 SHORT THREAD – STERILE EUDAMEDTOOL PRO Ø 7.0 x 90 SHORT 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
- SOS170090CS EUDAMEDSOS170090C EUDAMED7.0 x 90 mm - Short thread - Sterile FDA UDI
Identifiers
- Catalog Number
- SOS170090CS FDA UDI
- Primary DI / UDI-DI
- 08057717553901 EUDAMEDFDA UDI08057717557954 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 — 90 Millimeter FDA UDI
TOOL PRO Ø 7.0 x 90 SHORT THREAD – STERILE 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 |
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Manufacturer
- Manufacturer
- BRM Extremities S.r.l.
- EUDAMED SRN
- IT-MF-000016087
Sources (3)
- EUDAMED 7f59336b-43a2-4940-8974-c6bce34acff3 61 fields · synced Jul 27, 2026
- FDA UDI 71e12c14-b7bf-47c3-9688-9dc81e138c99 37 fields · synced May 30, 2026
- EUDAMED 6fc040a1-1969-4076-9ea2-ca298bdeab84 61 fields · synced Jul 27, 2026