OsteoMed
- Primary DI
- 00845694011853
- Brand
- OsteoMed
- Company
- OSTEOMED LLC
- Model
- 375-0012
- Catalog number
- 375-0012
- Device description
- Hemi Great Toe Implant Trial, 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 |
|---|
| 00845694011853 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00845694011853 | 00845694011853 | 845694011853 | 0845694011853 |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic implant/trial-implant holder, reusable | A hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft) or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Width | 23 | Millimeter |
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
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850044114962 | Accu-Joint | Accufix Surgical, Inc. | KWD | 2024-11-11 |
| 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 |
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