| Primary Device ID | 00810007633282 |
| NIH Device Record Key | 3b3f64f1-3341-4e31-8d94-ce36973122ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuStride System |
| Version Model Number | MC-3D132 |
| Catalog Number | MC-3D132 |
| Company DUNS | 144723868 |
| Company Name | Medcad |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net | |
| Phone | (214) 453-8864 |
| support@medcad.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810007633282 [Primary] |
| PBF | Orthopaedic Surgical Planning And Instrument Guides |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
[00810007633282]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-08 |
| Device Publish Date | 2025-06-30 |
| 00810007633268 | Titanium Surgical Guide |
| 00810007633251 | Surgical Plan - Report |
| 00081000763324 | Surgical Planning Kit |
| 00810007633244 | Surgical Planning Kit |
| 00810007633312 | ANATOMICAL MODEL, INTRAOPERATIVE, FOOT & ANKLE |
| 00810007633305 | ANATOMICAL MODEL, INTRAOPERATIVE, TIBIA, FIBULA |
| 00810007633299 | ANATOMICAL MODEL, INTRAOPERATIVE, FOOT, TIBIA, FIBULA |
| 00810007633282 | ANATOMICAL MODEL, INTRAOPERATIVE, FOOT |
| 00810007633329 | 3D Printed Titanium Plate |