FDA UDI
In Commercial Distribution
🇺🇸 United States
Unite Medical®
DI: 00850012035367
·
Model: Double Upright Knee Orthosis (Left,Small)
·
Unite Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Unite Medical®
- Primary DI
- 00850012035367
- Version / Model
- Double Upright Knee Orthosis (Left,Small)
- Catalog Number
- KO4552L-S
- 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
- 3e6b57a1-cd3b-4ada-b127-4686a1259f4c
Device Description
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
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 | 00850012035367 | GS1 |
Customer Contacts
- Phone
- 833.868.6483
- [email protected]