FDA UDI
In Commercial Distribution
🇺🇸 United States
ManaEZ 3 Panel Knee Immobilizer 20"
DI: 00810113683003
·
Model: EZ3PIMM01-20
·
Manamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ManaEZ 3 Panel Knee Immobilizer 20"
- Primary DI
- 00810113683003
- Version / Model
- EZ3PIMM01-20
- Catalog Number
- EZ3PIMM01-20
- Company Name
- Manamed, Inc.
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-25
- Public Version
- 2
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 69758d1e-4567-42c4-a0ef-4d8ac92096ea
Device Description
The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The combination of the posterior stay and two adjustable lateral stays maintains the optimum leg position. The popliteal pad ensures an intimate fit around the knee joint. Available in 18", 20", and 22" lengths in our single and three-panel design. Ideal for strains and sprains of the knee, stable fractures of the tibia, and patellar tendon repairs.
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
- Yes
- 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 |
|---|---|---|---|---|
| IQI | Orthosis, Limb Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12099 | Knee splint | A rigid, non-articulating, external support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113683003 | GS1 |
Customer Contacts
- Phone
- 888-508-0712
- [email protected]