OsteoMed
- Primary DI
- 00845694011730
- Brand
- OsteoMed
- Company
- OSTEOMED LLC
- Model
- 375-0000
- Catalog number
- 375-0000
- Device description
- Hemi Great Toe Implant Instrument Kit
- Published
- 2016-10-14
- 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 |
|---|
| 00845694011730 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845694011730 | 00845694011730 | 845694011730 | 0845694011730 |
GMDN Terms
| Term | Definition |
|---|
| Instrument tray | A container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. 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
- false
- Serial number
- true
- 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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| 00850061635037 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635198 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635204 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635211 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635228 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635235 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635242 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635259 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635266 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635273 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 00850061635280 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 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 |
| 00850061635327 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 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 |