FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Fixion Nailing System
DI: 07290109335643
·
Model: Proximal Femur Nail
·
CARBOFIX ORTHOPEDICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fixion Nailing System
- Primary DI
- 07290109335643
- Version / Model
- Proximal Femur Nail
- Catalog Number
- 436L138
- Company Name
- CARBOFIX ORTHOPEDICS LTD
- Labeler DUNS
- 649185170
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-07
- Public Version
- 5
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- da16ff62-996c-4018-98e7-d7d2ba76a726
- Distribution End Date
- 2024-05-30
Device Description
The proximal femur intramedullary nail is intended for use in the fixation of proximal fractures in the femur.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33187 | Femur intramedullary nail | A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109335643 | GS1 |
Customer Contacts
- Phone
- +97299511511
- [email protected]
- Phone
- 1-800-408-0120
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Right/Left: L | ||
| Angle | 125 | degree | |
| Length | 380 | Millimeter | |
| Device Size Text, specify | Insertion Diameter: 10 Millimeter | ||
| Device Size Text, specify | Expanded Diameter: 16 Millimeter | ||
| Device Size Text, specify | Proximal Diameter: 14 Millimeter |