Thrive Orthopedics
- Primary DI
- 00810079190089
- Brand
- Thrive Orthopedics
- Company
- Thrive Orthopedics LLC
- Model
- F3 AFO Xtra Large Left
- Device description
- F3 AFO Dynamic Feedback Anterior Ankle Foot Orthosis Xtra Large Left
- Published
- 2023-09-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| IQI | Orthosis, Limb Brace |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IQI | Orthosis, Limb Brace | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810079190089 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Ankle/foot orthosis | A prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device. |
Regulatory Flags
- DUNS number
- 035286635
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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