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Brm Tool Screws Instrument
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref STOIKW12120810N
Identity
- Trade Name
- K-Wire Ø 1.2 x 120 (80mm Marker) EUDAMEDBRM TOOL SCREWS INSTRUMENT FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- Fili di Kirschner EUDAMED
- Model / Reference
- STOIKW12120810N EUDAMEDK-Wire Ø 1.2 x 120 (80mm Marker) FDA UDI
Identifiers
- Catalog Number
- STOIKW12120810N FDA UDI
- Primary DI / UDI-DI
- 08053782780877 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT09B5CB EUDAMED
- Unit of Use DI
- 18053782780874 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P09120301 KIRSCHNER BONE WIRES EUDAMED
- GMDN Term
- Orthopaedic guidewire, single-use 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
Yes
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: Orthopaedic guidewire, single-use
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 Orthopaedic guidewire, single-use.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
- HINGE PEDIATRIC PLATING 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 30616a72-3820-4dfb-bd2e-6451de3ba200 35 fields · synced Jul 10, 2026
- EUDAMED 136ae5d1-3548-4d0c-b63e-57d88f8612f4 61 fields · synced Jul 10, 2026