M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512280840
- Version / Model
- 574 XL
- Catalog Number
- 574
- 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
- c35d53a4-e464-454a-b24e-57771aa9c4d9
Device Description
The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible steel stays, a covered lumbar thermoplastic panel, an abdominal thermoplastic panel and two lateral panels. The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. INDICATIONS : Supports from sacrum to T-9 level. Post-op: Following stabilizing surgery, following lumbar disk surgery. The addition of lateral panels makes this brace indicated for the treatment of burst fractures. Degenerative pathologies: Osteoporosis, lumbar-sacral vertebrae complaint, protrusions, arthrosis. Muscular pathologies: Muscular contractures. Practical and easy to fit, it adapts perfectly to your body. This corset acts as a corrective measure and as a support to postural defects. Breathable and non allergenic, 100% cotton
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 |
|---|---|---|---|---|
| IPY | Orthosis, Lumbo-Sacral | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33031 | Lumbar spine orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512285661 | GS1 | Box Case | 10 | In Commercial Distribution | |
| Primary | 05391512280840 | GS1 |
Customer Contacts
- Phone
- 1-866-374-4050
- [email protected]