FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Brace Air
DI: 05391512280253
·
Model: 20 R
·
INDACO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M-Brace Air
- Primary DI
- 05391512280253
- Version / Model
- 20 R
- Catalog Number
- 20
- Company Name
- INDACO SRL
- Labeler DUNS
- 338470646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-13
- Public Version
- 1
- Public Version Date
- 2024-02-21
- Public Version Status
- New
- Public Device Record Key
- 9da3bd7b-5a18-44ab-b3bd-6aee75624e77
Device Description
The Knee Wrap is used as a protective support following muscular, articular or ligament injuries of the patellar region. Two different materials were used in its construction; the inside is made of soft cotton velour that is breathable and does not cause skin irritation and the outside is a special nylon that permits the Velcro to grip and stay fastened. Recommended for overall general knee pain. INDICATIONS • Support and compression for light patellar trauma. • Easy adjustments superior to patella or inferior to the patella, depending on the degree of compression needed. • Completely adjustable, two sizes only. • Neoprene and Latex free.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41065 | Knee support orthosis | A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391512285173 | GS1 | Box Case | 12 | In Commercial Distribution | |
| Primary | 05391512280253 | GS1 |
Customer Contacts
- Phone
- 866-374-4050
- [email protected]