Identity
- Trade Name
- FEMORAL BRUSH FDA UDI
- Generic Name
- Intramedullary canal cleaning brush, single-use FDA UDI
- Device Name
- FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullary canal. It is intended to be used for helping the surgeons, during the fixation of artificial joint prosthesis with the acrylic bone cement, in cleaning the femoral canal from debris after the canal has been drilled and before the cement application. FDA UDI
- Model / Reference
- SPZ-01 FDA UDI
- Description
- FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullary canal. It is intended to be used for helping the surgeons, during the fixation of artificial joint prosthesis with the acrylic bone cement, in cleaning the femoral canal from debris after the canal has been drilled and before the cement application. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031497002668 FDA UDI
- FDA Product Code
- GEC FDA UDI
- GMDN Term
- Intramedullary canal cleaning brush, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intramedullary canal cleaning brush, single-use
Femoral Brush by Tecres — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tecres
Sources (1)
- FDA UDI be9a9724-8c76-4dbf-827e-3d3691041d9d 33 fields · synced Jun 8, 2026