FDA UDI
In Commercial Distribution
🇺🇸 United States
FEMORAL BRUSH
DI: 08031497002668
·
Model: SPZ-01
·
TECRES SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FEMORAL BRUSH
- Primary DI
- 08031497002668
- Version / Model
- SPZ-01
- Company Name
- TECRES SPA
- Labeler DUNS
- 435428396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-23
- Public Version
- 1
- Public Version Date
- 2022-10-03
- Public Version Status
- New
- Public Device Record Key
- be9a9724-8c76-4dbf-827e-3d3691041d9d
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47690 | Intramedullary canal cleaning brush, single-use | A sterile, hand-held, manual surgical instrument designed to remove blood clots and bone debris from the intramedullary canal of a bone (marrow space) in preparation for the insertion of orthopaedic cement. It typically consists of a handle at the proximal end and bristles or fibres at the distal end. The stiff bristles or fibres radiate out around a central shaft which may be flexible or rigid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08031497002668 | GS1 |