FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Brace Air
DI: 05391512282066
·
Model: 137 R
·
INDACO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512282066
- Version / Model
- 137 R
- Catalog Number
- 137
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-22
- Public Version
- 1
- Public Version Date
- 2024-03-01
- Public Version Status
- New
- Public Device Record Key
- 92fd065d-ead1-438f-9fbd-4838ca3e3f25
Device Description
The 137 is an accessory only, must be used with product 134 or 136 wrist splints only. The main features of the M-Brace Thumb splint are: -an advanced fabric ensuring a very confortable touch while allowing the skin to breathe; -right and left models available; -a structure which can be totally opened so that wearing the splint is easy and painless; -moldable support. RIZOFIX, the patented thumb block system immobilizes the thumb from the inner side, leaving the opposite side free. INDICATIONS: Traumatic pathologies: distortions, carpal-metacarpal fractures, tendonitis. Degenerative pathologies: root arthrosis, carpal tunnel syndrome, arthrosis. Rehab phase: provides post-trauma and post-op tendon muscle relief.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| 41461 | Wrist/hand/metacarpophalangeal joint extension orthosis | An externally applied orthopaedic appliance or apparatus designed to assist in the extension of the wrist, hand, and metacarpophalangeal joints (MP joints or knuckles). The device has an outrigger (a projecting support) to assist in the extension of the thumb. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512286965 | GS1 | Box Case | 24 | In Commercial Distribution | |
| Primary | 05391512282066 | GS1 |
Customer Contacts
- Phone
- 866-374-4050
- [email protected]