FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Brace Air
DI: 05391512281038
·
Model: 576 M
·
INDACO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512281038
- Version / Model
- 576 M
- Catalog Number
- 576
- 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
- 06305c25-c3bf-461e-8a8d-b790fb2ea1f0
Device Description
Made of an elastic fabric, the CLAVICLE SUPPORT is comfortable and easy to put on. It is composed of two bands to be worn on the right and left shoulder, crossed behind the back and then locked together on the abdomen at the desired tightness. The constant support of the shoulders relaxes the pectoral muscles and improves posture. To ensure maximum comfort especially during extended use, this product was made with a breathable fabric. INDICATIONS • Rigid or falling shoulders • Bad posture • Clavicle injuries
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 |
|---|---|---|---|---|
| NJB | Orthosis, Truncal, For Dysmenorrhea | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13810 | Clavicle orthosis | A prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It is formed as a figure-of-eight harness that descends from the shoulders, passes under each arm and crosses over the back. It has broad, padded straps and may have extra padding inserted at the back. This device may also be used to improve the patient's posture. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512286552 | GS1 | Box Case | 10 | In Commercial Distribution | |
| Primary | 05391512281038 | GS1 |
Customer Contacts
- Phone
- 866-374-4050
- [email protected]