ORTHOMED
- Primary DI
- B8037101243
- Brand
- ORTHOMED
- Company
- ORTHO-MED, INC.
- Model
- OM 71-0124
- Catalog number
- OM 71-0124
- Device description
- K-WIRE DBL.TROCAR PT.12".054" 1.4MM
- Published
- 2020-05-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| HTY | Pin, Fixation, Smooth |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HTY | Pin, Fixation, Smooth | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B8037101243 | Package | HIBCC | 6 | In Commercial Distribution |
| B8037101240 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic bone wire | A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 086618626
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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