FDA UDI
In Commercial Distribution
🇺🇸 United States
Aura
DI: 00841747186707
·
Model: APKA 150
·
COLLEGE PARK INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aura
- Primary DI
- 00841747186707
- Version / Model
- APKA 150
- Company Name
- COLLEGE PARK INDUSTRIES, INC.
- Labeler DUNS
- 623191137
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-19
- Public Version
- 1
- Public Version Date
- 2024-06-27
- Public Version Status
- New
- Public Device Record Key
- 0e5b7401-9566-4cbb-b92d-b519fb0ca3ef
Device Description
Aura Polycentric Knee Assembly
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ISY | Joint, Knee, External Limb Component | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64719 | Hydraulic/pneumatic external knee prosthesis | A device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on hydraulics and/or pneumatics (e.g., using fixed fluid orifices, or needle or servo valves). It responds to changes in motion by providing variable damping through progressive adjustments [i.e. over several steps] in motion resistance. It may have various designs and functional features (e.g., monocentric or polycentric, manual lock, stance flexion) for support during a variety of activities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841747186707 | GS1 |