M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512284350
- Version / Model
- 66T
- Catalog Number
- 66T
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-13
- Public Version
- 1
- Public Version Date
- 2024-02-21
- Public Version Status
- New
- Public Device Record Key
- b5f7b354-182b-4ad4-bd9d-bae629db6ba2
Device Description
Telescopic Post-Operative Knee Brace (#66T) This medical device is a Post-Op Knee brace with articulated telescopic bars in light aluminium alloy, padded by soft MTP and sponge fabric in contact with skin to reduce sweating. It has separate bands in order to ensure greater breathability of the leg and valves for belts specially designed to reduce the pressure of the bands. It also has adjustable strap closures that insures the orthosis is tightly secured to the limb. The knee brace has a Range of Motion Joint, adjustment of flexion and extension at 10° (flexion 0° / 120°; extension 0° / 90°) and an option to block joint every 10°. It contains condylar protective detachable pads. Its shape provides an excellent anatomic stabilization of the limb and comfortable to wear and use. One size fits all. L1832 or L1833 approved. INDICATIONS Post-operative knee ligament reconstruction treatment, complete prosthesis, femoral or tibia fractures at the knee, valgus and varus osteotomy. Recommended to treat post-traumatic knee strain requiring semi-flexion immobilization.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41065 | Knee support orthosis | A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512286538 | GS1 | Box Case | 6 | In Commercial Distribution | |
| Primary | 05391512284350 | GS1 |
Customer Contacts
- Phone
- 1-866-374-4050
- [email protected]