OsteoMed
- Primary DI
- 00845694011259
- Brand
- OsteoMed
- Company
- OSTEOMED LLC
- Model
- 360-2240
- Catalog number
- 360-2240
- Device description
- Inter-Phalangeal Stabilization Rod, 4.0mm
- Published
- 2015-05-22
- Public version status
- Update
- Distribution status
- 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 |
|---|
| 00845694011259 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845694011259 | 00845694011259 | 845694011259 | 0845694011259 |
GMDN Terms
| Term | Definition |
|---|
| Partial metatarsophalangeal joint prosthesis | A sterile implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and implantation may be performed with or without bone cement. The device 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 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store at controlled room temperature out of direct sunlight |
Regulatory Flags
- DUNS number
- 606417780
- Device count
- 1
- DM exempt
- true
- 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
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
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|---|
| 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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