| Primary Device ID | 03760297030193 |
| NIH Device Record Key | c1e46d69-7611-49b4-9159-6ecc4cdcc9f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Instruments box |
| Version Model Number | Knee+ |
| Catalog Number | BIN002 |
| Company DUNS | 270195749 |
| Company Name | PIXEE MEDICAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760297030193 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
[03760297030193]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-18 |
| Device Publish Date | 2021-10-08 |
| 03760297030438 - Orientation and resection mechanism | 2025-04-28 Reusable instrument for Total Knee Arthroplasty |
| 03760297030445 - Adjustable cutting guide adaptor | 2025-04-28 Reusable instrument for Total Knee Arthroplasty |
| 03760297030452 - KneeTools Instrument Box V6 | 2025-04-28 Storage box for orthopedic surgical instruments |
| 03760297030469 - KneePlus | 2025-04-28 Software for Total Knee Arthroplasty |
| 03760297030483 - Kit KneeTools V6 | 2025-04-28 Kit of reusable instruments for Total Knee Arthroplasty |
| 03760297030285 - Modular Pointer | 2025-04-21 Reusable instrument for Total Knee Arthroplasty |
| 03760297030223 - SHA Outer ring | 2023-06-26 |
| 03760297030247 - SHA Connector | 2023-06-26 |