M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512280451
- Version / Model
- 75 M
- Catalog Number
- 75
- 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
- f988a452-8e49-4cf9-aa00-53eda2eeb314
Device Description
The Knee Brace # 75 Artemis Light MCL-LCL Instability is for both right and left knees providing optimal support and protection following muscle, joint and/or tendon injuries, LCL MCL weakness. It is constructed exclusively from breathable hypoallergenic fabrics (neoprene and latex free), the area which comes into contact with the skin is made of soft 100% cotton. An exclusive handy locking system allows the required pressure to be varied in two different areas - 2 molded aluminum hinges (lateral and medial) for optimal lateral support- 2 low profile 2mm super light rods, to keep the brace in place during compression therapy. Indications ° Traumatic pathologies: light distortions, light articular laxity, bursitis, articular effusion. ° Rehab phase: passive support during rehab, light protection during sports. ° Offers compression and slight re- alignment in the presence of mild osteorthratis ° Anatomically shaped medial and lateral aluminum polycentric hinges guarantee a complete synchrony with the natural movement of the knee. ° Breathable, 100% cotton on your skin.
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 | 05391512285371 | GS1 | Box Case | 10 | In Commercial Distribution | |
| Primary | 05391512280451 | GS1 |
Customer Contacts
- Phone
- 1-866-374-4050
- [email protected]