FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Brace Air
DI: 05391512280123
·
Model: 15 R
·
INDACO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512280123
- Version / Model
- 15 R
- Catalog Number
- 15
- 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
- 03c7aac4-8922-401d-b9d3-8d5d65b56059
Device Description
The Mercurio Ankle Lock brace, with elastic, reinforced strap to be applied to the ankle using our locking system. In order to ensure maximum comfort and tolerance, especially in the case of extended use, particular care and attention have been dedicated to the selection of materials and fabrics. As such, our products are made exclusively with all natural, hypo-allergenic and breathable fibers. The inside fabric of this product is the result of a unique technology. It is made with very soft cotton velour providing the skin with an extremely comfortable touch and at the same time, allowing it to breathe freely all day-even while playing sports.
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 | 05391512285043 | GS1 | Box Case | 12 | In Commercial Distribution | |
| Primary | 05391512280123 | GS1 |
Customer Contacts
- Phone
- 8663744050
- [email protected]