Elite Orthopaedics
- Primary DI
- 00816591013271
- Brand
- Elite Orthopaedics
- Company
- Elite Orthopaedics, Inc.
- Model
- T98426
- Catalog number
- T98426
- Device description
- FSX Air Walker, High Top, Large
- Published
- 2023-08-04
- 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
- true
Product Codes
| Code | Name |
|---|
| ITW | Joint, Ankle, External Brace |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ITW | Joint, Ankle, External Brace | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00816591013271 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00816591013271 | 00816591013271 | 816591013271 | 0816591013271 |
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
- 803168228
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- 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
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|---|
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