M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512281915
- Version / Model
- 132 E
- Catalog Number
- 132
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-22
- Public Version
- 1
- Public Version Date
- 2024-03-01
- Public Version Status
- New
- Public Device Record Key
- 6d6ea5f9-63d2-4d23-8a44-afc83eea8816
Device Description
This Wrist Support has been designed and produced as a support and protective device for muscular minor damages, as well as for tendon and joint inflammations either caused by light trauma, stress or excessive fatigue. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to the specific construction, this brace can be worn and positioned very easily. The tension can be adjusted according to individual needs. NON-ELASTIC. Patented M-Brace technology. INDICATIONS • For light traumas and minor injuries of the wrist. • Post-trauma rehab and prevention during sports. Easily adjustable compression. • 100% breathable. • Patented M-Brace technology. • Neoprene and latex 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 |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43817 | Wrist binder, reusable | A dedicated strip/roll of fabric or polymer material designed to be wrapped around the wrist to support the wrist joint. It does not include a rigid support (i.e., not a wrist immobilizer) and is not a tubular support bandage. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512286859 | GS1 | Box Case | 24 | In Commercial Distribution | |
| Primary | 05391512281915 | GS1 |
Customer Contacts
- Phone
- 1-866-374-4050
- [email protected]