OsteoMed
- Primary DI
- 00845694011792
- Brand
- OsteoMed
- Company
- OSTEOMED LLC
- Model
- 375-0006
- Catalog number
- 375-0006
- Device description
- Hemi Great Toe Implant Sizer, Medium/Large
- Published
- 2016-07-21
- Public version status
- Update
- 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 |
|---|
| KWD | PROSTHESIS, TOE, HEMI-, PHALANGEAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00845694011792 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845694011792 | 00845694011792 | 845694011792 | 0845694011792 |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic fixation implant alignment tool | A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
Other Devices Sharing Product Codes
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|---|
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| 00850061635228 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635235 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
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| 00850061635266 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
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| 00850061635297 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635303 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635310 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
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| 00850061635334 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635341 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635358 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850005618102 | BioPoly® Lesser Toe Hemiarthroplasty Implant | Biopoly, LLC | KWD | 2023-10-25 |
| 00850005618119 | BioPoly® Lesser Toe Hemiarthroplasty Implant | Biopoly, LLC | KWD | 2023-10-25 |
| 00850005618126 | BioPoly® Lesser Toe Hemiarthroplasty Implant | Biopoly, LLC | KWD | 2023-10-25 |
| 00850005618133 | BioPoly® Lesser Toe Hemiarthroplasty Implant | Biopoly, LLC | KWD | 2023-10-25 |
| 00850005618140 | BioPoly® Lesser Toe Hemiarthroplasty Implant | Biopoly, LLC | KWD | 2023-10-25 |
| 00850044114894 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2023-09-11 |
| 00850044114900 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2023-09-11 |
| 00850044114917 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2023-09-11 |
| 00840097505220 | restor3d MTP | Restor3d | KWD | 2023-04-03 |
| 00840097505237 | restor3d MTP | Restor3d | KWD | 2023-04-03 |
| 00840097505244 | restor3d MTP | Restor3d | KWD | 2023-04-03 |
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