M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512280147
- Version / Model
- 16 M
- Catalog Number
- 16
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-26
- Public Version
- 1
- Public Version Date
- 2024-02-05
- Public Version Status
- New
- Public Device Record Key
- 1aaf4574-cbc5-4a7d-9f7f-79f6bc913441
Device Description
The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. 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 |
|---|---|---|---|---|
| 44481 | Ankle binder, reusable | A strip or roll of fabric or plastic material designed to be wrapped around the ankle to help stabilize and support the joint. It does not include a rigid support (i.e., not an ankle/foot orthosis) and is not a tubular support bandage. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512285067 | GS1 | Box Case | 12 | In Commercial Distribution | |
| Primary | 05391512280147 | GS1 |
Customer Contacts
- Phone
- 1-866-374-4050
- [email protected]