Identity
- Trade Name
- Basic countersink Ø 3.2 EUDAMEDBRM TOOL SCREWS INSTRUMENT FDA UDI
- Generic Name
- Surgical countersink, reusable FDA UDI
- Device Name
- Strumenti chirurgici riutilizzabili accessori alle Viti per Osteosintesi EUDAMED
- Model / Reference
- STOI23200BK EUDAMEDBasic countersink Ø 3.2 FDA UDI
Identifiers
- Catalog Number
- STOI23200BK FDA UDI
- Primary DI / UDI-DI
- 08053782780174 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT08C1BZ EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical countersink, 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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: Surgical countersink, 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 Surgical countersink, reusable.
- WIDE COUNTERSINK DRILL - LONG — BIOTECHNOLOGY INSTITUTE SL · Class I
- Zimmer Cannulated Screw System — Pioneer Surgical Technology, Inc. · Class I
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- COUNTERSINK SMALL FRAG — Biomet Orthopedics, Inc. · Class I
- Cortical Counter Sink — I.T.S. GmbH · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- PERLA ® — Spineart · Class II
- DART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC. · 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 46f34b61-3987-4d39-a2e3-ae6ef397f0f0 35 fields · synced Jun 18, 2026
- EUDAMED fe99525b-4dee-40f4-b6b3-46a2ed0c583d 61 fields · synced Jun 18, 2026