M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512280239
- Version / Model
- 80 R
- Catalog Number
- 80
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-15
- Public Version
- 1
- Public Version Date
- 2024-02-23
- Public Version Status
- New
- Public Device Record Key
- 414f273d-169c-425f-93dd-080a58f8fbc5
Device Description
The M-Brace #80 Thigh Wrap insures a constant pressure on the quadriceps and the hamstrings following muscle strains to alleviate pain and to shorten the healing process. Different materials were used in its construction among which two in particular; the inside is made of soft cotton velour that is breathable and does not cause skin irritation and the outside is a special nylon that permits the Velcro to grip and stay fastened. The wrap can be perfectly adjusted. It comes with an inside pad that can be positioned in the exact place of injury. To ensure maximum comfort especially during extended use, this product was made with a breathable fabric. INDICATIONS Indicated for muscles strains (quad or femoral bicep). Alleviates pain by exerting a constant compression on the injured muscular fibers which in turn helps in the healing process. Strongly indicated for use during sport. Made with our exclusive AIRFLEX fabric. 100% cotton on the skin; it is breathable, hypo allergenic and neoprene free.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MHW | Dressing, Compression | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64438 | Compression/pressure tubular garment | A device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512285159 | GS1 | Box Case | 10 | In Commercial Distribution | |
| Primary | 05391512280239 | GS1 |
Customer Contacts
- Phone
- 8663744050
- [email protected]