Futura™ FDI
- Primary DI
- 00846832006557
- Brand
- Futura™ FDI
- Company
- TORNIER, INC.
- Model
- FDI-20
- Published
- 2015-10-16
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| KWH | PROSTHESIS, TOE, CONSTRAINED, POLYMER |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00846832006557 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00846832006557 | 00846832006557 | 846832006557 | 0846832006557 |
GMDN Terms
| Term | Definition |
|---|
| Total metatarsophalangeal joint prosthesis, one-piece | A sterile implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 968990812
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00819034029181 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | KWH | 2023-07-14 |
| 00819034029198 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | KWH | 2023-07-14 |
| 00819034029211 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | KWH | 2023-07-14 |
| 00840124507456 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | KWH | 2023-07-14 |
| 00840124508989 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | KWH | 2023-07-14 |
| 00885556834244 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834268 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834282 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834305 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834329 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834374 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834398 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834411 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834435 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834534 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834558 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834572 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 00885556834596 | Silicone Toe System | Smith & Nephew, Inc. | KWH | 2022-12-22 |
| 08057717550801 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550818 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550825 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550832 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550849 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550856 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550863 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550870 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550887 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 08057717550894 | Silktoe Spacer | BRM EXTREMITIES SRL | KWH | 2021-10-17 |
| 00840124506138 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | KWH | 2021-08-18 |
| 00840124506145 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | KWH | 2021-08-18 |
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