LOCK DEVICES
- Primary DI
- 00713980001331
- Brand
- LOCK DEVICES
- Company
- Alps South, LLC
- Model
- FAB946
- Device description
- Fabrication Kit
- Published
- 2024-12-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| IRA | Hand, External Limb Component, Mechanical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IRA | Hand, External Limb Component, Mechanical | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00713980001331 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| External lower-limb prosthesis suspensory component, non-powered | A non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap, sleeve, cuff, thigh corset, shell, belt, pin, lock, valves). |
Regulatory Flags
- DUNS number
- 824697569
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 04719883463494 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IRA | 2025-01-10 |
| 04719883463500 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IRA | 2025-01-10 |
| 04719883463517 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IRA | 2025-01-10 |
| 04719883463524 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IRA | 2025-01-10 |
| 04719883463531 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | IRA | 2025-01-10 |
| 00713980001348 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001355 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001362 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001379 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001386 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001393 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001409 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001416 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001423 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001430 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980001447 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980004332 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980004615 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980005131 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980005148 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980005179 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980005384 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980006008 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980006015 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980006046 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980008620 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980008637 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980008644 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980008651 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |
| 00713980008668 | LOCK DEVICES | Alps South, LLC | IRA | 2024-12-30 |