FDA UDI
In Commercial Distribution
🇺🇸 United States
ManaMed
DI: 00810113681764
·
Model: EZOA Right
·
MANAMED INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ManaMed
- Primary DI
- 00810113681764
- Version / Model
- EZOA Right
- Catalog Number
- OFF001R
- Company Name
- MANAMED INC
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-21
- Public Version
- 2
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- 4877d529-3258-476d-9f6a-1096c77194f8
Device Description
The EZOA is a universal OA brace that allows for a varus or valgus tilt in one brace. Indicated for patients with knee arthritis. Low profile, single upright hinge for daily activities Adjustment wrench allows for easy adjustment Straps and cushions designed for all day support Lightweight, easy to use Universally sized, but left or right specific
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 | 00810113681764 | GS1 |
Customer Contacts
- Phone
- 888-508-0712
- [email protected]