FDA UDI
In Commercial Distribution
🇺🇸 United States
Lunaris® Essential
DI: 05404036502869
·
Model: Lunaris Essential
·
Axiles Bionics
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lunaris® Essential
- Primary DI
- 05404036502869
- Version / Model
- Lunaris Essential
- Catalog Number
- LESC6SXXZ
- Company Name
- Axiles Bionics
- Labeler DUNS
- 371723288
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-12
- Public Version
- 1
- Public Version Date
- 2025-05-20
- Public Version Status
- New
- Public Device Record Key
- 1a4ad404-49a3-4743-a15c-0011c2d1a8d4
Device Description
Articulated prosthetic ankle-foot component with spring category C6. The device is intended for the replacement of the ankle and foot function as a component of a prosthesis that compensates for an absent or deficient lower limb.
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 |
|---|---|---|---|---|
| ISH | Component, External, Limb, Ankle/Foot | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64723 | Mechanical-resistance external ankle-foot prosthesis | A mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) 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 | 05404036502869 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Centimeter | |
| Length | 25 | Centimeter | |
| Length | 26 | Centimeter | |
| Length | 27 | Centimeter | |
| Length | 28 | Centimeter | |
| Length | 29 | Centimeter | |
| Length | 30 | Centimeter | |
| Device Size Text, specify | Side, Left (L) / Right (R) |