FDA UDI
In Commercial Distribution
🇺🇸 United States
LimbLogic
DI: 00194711300495
·
Model: LLV-21043SU
·
Willowwood Global LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LimbLogic
- Primary DI
- 00194711300495
- Version / Model
- LLV-21043SU
- Catalog Number
- LLV-21043SU
- Company Name
- Willowwood Global LLC
- Labeler DUNS
- 004280723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-21
- Public Version
- 1
- Public Version Date
- 2025-03-31
- Public Version Status
- New
- Public Device Record Key
- bce819af-7ed3-4278-a043-a021b995ab9b
Device Description
LimbLogic 2, 4-Hole Service Unit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ISP | Valve, Prosthesis | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64716 | External lower-limb prosthesis suspensory component, powered | A powered device intended to be integrated in the socket of an external lower limb prosthesis to provide prosthesis suspension by reducing the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It is designed as a vacuum pump (e.g., electric, mechanical) to provide increased vacuum inside the socket. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00194711300495 | GS1 |
Customer Contacts
- Phone
- 740-869-3377
- [email protected]