FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Brace Air
DI: 05391512281304
·
Model: 35 RS
·
INDACO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512281304
- Version / Model
- 35 RS
- Catalog Number
- 35
- 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
- b50687da-ee4f-4b74-a89f-9cfba17fe7a7
Device Description
The main features of the M-Brace Thumb splint are: • made exclusively from breathable and non-allergic materials • right and left models available • opens completely for an easy and painless fit • patented Rizofix feature that immobilizes the thumb and allows for easy positioning. NDICATIONS • 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
- 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 |
|---|---|---|---|---|
| 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 | 05391512286606 | GS1 | Box Case | 16 | In Commercial Distribution | |
| Primary | 05391512281304 | GS1 |
Customer Contacts
- Phone
- 866-374-4050
- [email protected]