8mm Drill
- Primary DI
- 00819251022286
- Brand
- 8mm Drill
- Company
- TOTAL JOINT ORTHOPEDICS, INC.
- Model
- 2111.00.000
- Device description
- 8mm Drill
- Published
- 2019-10-24
- 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 |
|---|
| HTW | Bit, Drill |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HTW | Bit, Drill | Orthopedic | 1 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00819251022286 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Cannulated surgical drill bit, reusable | A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
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
Other Devices From This Company
| 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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