M-Brace Air
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512282011
- Version / Model
- 134 LE
- Catalog Number
- 134
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-14
- Public Version
- 1
- Public Version Date
- 2024-02-22
- Public Version Status
- New
- Public Device Record Key
- 0adfd6a0-4dd6-44db-b309-0307799ba2bc
Device Description
This Wrist Splint has been designed and produced as a support and protective device for muscular damages, as well as for tendon and joint injuries either caused by trauma, stress or excessive fatigue. Available in right or left for a perfect fit and superior comfort. 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 this specific construction, a vast range of closing positions are available, depending on the tension desired. The two aluminum stays, pre-shaped and moldable for custom fitting, can be removed according to the need of immobilization of the patient.
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 |
|---|---|---|---|---|
| ILH | Splint, Hand, And Components | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41459 | Wrist/hand orthosis | An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512286910 | GS1 | Box Case | 12 | In Commercial Distribution | |
| Primary | 05391512282011 | GS1 |
Customer Contacts
- Phone
- 8663744050
- [email protected]