Identity
- Trade Name
- Cannulated Drill Bit Ø 2.7mm KW 12 EUDAMEDBRM TOOL SCREWS INSTRUMENT FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- Strumenti chirurgici accessori all'impianto delle Viti per Osteosintesi EUDAMED
- Model / Reference
- STOI227012P EUDAMEDCannulated Drill Bit Ø 2.7mm KW 12 FDA UDI
Identifiers
- Catalog Number
- STOI227012P FDA UDI
- Primary DI / UDI-DI
- 08053782781621 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT09B1C3 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Cannulated surgical drill bit, 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cannulated surgical drill bit, reusable
Brm Tool Screws Instrument by Brm Extremities — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill bit, reusable.
- Thunderbolt — RESPONSIVE ORTHOPEDICS LLC · Class I
- 4.0 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc · Class II
- GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC · Class I
- EBA2 — Citieffe · Class II
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- DynaNail — Medshape, Inc. · Class I
- BIXCUT — Stryker Corp. · Class I
- FREE GLIDING SCFE SCREW SYSTEM — Orthopediatrics Canada ULC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brm Extremities
Sources (2)
- FDA UDI 683ed71c-c9fb-48af-8e1f-04b1aff86c0c 35 fields · synced Jul 30, 2026
- EUDAMED eb0954f8-a3fe-46b9-b469-774e80948a8b 61 fields · synced Jul 30, 2026