Klassic Knee Case 3, Patella/Misc. Preparation Instrumentation
- Primary DI
- 00819251023399
- Brand
- Klassic Knee Case 3, Patella/Misc. Preparation Instrumentation
- Company
- TOTAL JOINT ORTHOPEDICS, INC.
- Model
- 2403.00.000
- Device description
- Knee Case 3, Patella/Misc. Preparation Instrumentation
- Published
- 2019-11-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| FSM | TRAY, SURGICAL, INSTRUMENT |
| OJH | Orthopedic Tray |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
| OJH | Orthopedic Tray | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00819251023399 | Primary | GS1 | 0 | |
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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | The Klassic Knee System should be stored in a clean, dry location at room
temperature |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +1(801)486-6070 | udi@tjoinc.com |
Regulatory Flags
- DUNS number
- 078416717
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00810094692728 | CR Femoral Trial, Grit Blasted | SRI-10051.01 | | 2026-02-05 |
| 00810094692735 | CR Femoral Trial, Grit Blasted | SRI-10051.02 | | 2026-02-05 |
| 00810094692742 | CR Femoral Trial, Grit Blasted | SRI-10051.03 | | 2026-02-05 |
| 00810094692759 | CR Femoral Trial, Grit Blasted | SRI-10051.04 | | 2026-02-05 |
| 00810094692766 | CR Femoral Trial, Grit Blasted | SRI-10051.05 | | 2026-02-05 |
| 00810094692773 | CR Femoral Trial, Grit Blasted | SRI-10051.06 | | 2026-02-05 |
| 00810094692780 | CR Femoral Trial, Grit Blasted | SRI-10051.07 | | 2026-02-05 |
| 00810094692674 | Klassic Knee Template, Tibial Baseplate, Revision | 2909.00.000 | | 2026-01-07 |
| 00810094692476 | Narrow Distal Femur Cut Block | SRI-10047 | | 2025-08-27 |
| 00810094692544 | Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert | 2417.00.200 | | 2025-07-28 |
| 00810094692339 | Acetabular Reamer Adapter | SRI-10044 | | 2025-06-26 |
| 00810094691790 | Klassic Knee Templates, Stem Extensions | 2806.00.000 | | 2025-05-14 |
| 00810094692322 | Spline Wrench, Closed | 2017.00.100 | | 2025-05-14 |
| 00810094692346 | Intramedullary Reamer, Revision | 2026.10.000 | | 2025-05-14 |
| 00810094692353 | Intramedullary Reamer, Revision | 2026.11.000 | | 2025-05-14 |
| 00810094692360 | Intramedullary Reamer, Revision | 2026.12.000 | | 2025-05-14 |
| 00810094692377 | Intramedullary Reamer, Revision | 2026.13.000 | | 2025-05-14 |
| 00810094692384 | Intramedullary Reamer, Revision | 2026.14.000 | | 2025-05-14 |
| 00810094692391 | Intramedullary Reamer, Revision | 2026.15.000 | | 2025-05-14 |
| 00810094692407 | Intramedullary Reamer, Revision | 2026.16.000 | | 2025-05-14 |
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