FDA UDI
In Commercial Distribution
🇺🇸 United States
Unite Medical®
DI: 00850012035121
·
Model: Universal ROM Knee Brace
·
Unite Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Unite Medical®
- Primary DI
- 00850012035121
- Version / Model
- Universal ROM Knee Brace
- Catalog Number
- KO3233
- Company Name
- Unite Medical, LLC
- Labeler DUNS
- 117553945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-28
- Public Version
- 1
- Public Version Date
- 2024-01-05
- Public Version Status
- New
- Public Device Record Key
- 04667a3e-fd6f-4d0a-a71b-44f25a0ac6d0
Device Description
The Unite Medical® Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
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 |
|---|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 890.3475 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00850012035121 | GS1 |
Customer Contacts
- Phone
- 833.868.6483
- [email protected]