NexFix
- Primary DI
- 00846832018918
- Brand
- NexFix
- Company
- TORNIER, INC.
- Model
- NCS-3RCS
- Catalog number
- NCS-3RCS
- Device description
- COUNTERSINK
- Published
- 2022-08-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HWW | Countersink | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00846832018918 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00846832018918 | 00846832018918 | 846832018918 | 0846832018918 |
GMDN Terms
| Term | Definition |
|---|
| Surgical countersink, reusable | A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 968990812
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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| 04042409452826 | NA | aap Implantate AG | HWW | 2025-02-26 |
| 04042409452864 | NA | aap Implantate AG | HWW | 2025-02-26 |
| 10888277373754 | MEDLINE | MEDLINE INDUSTRIES, INC. | HWW | 2025-02-21 |
| 10888277379152 | MEDLINE | MEDLINE INDUSTRIES, INC. | HWW | 2025-02-21 |
| 10888277390072 | MEDLINE | MEDLINE INDUSTRIES, INC. | HWW | 2025-02-21 |
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| 00810028395077 | 2.0/2.4 Countersink | Trilliant Surgical, LLC | HWW | 2024-06-07 |
| 00810028395084 | 3.0/4.0 Countersink | Trilliant Surgical, LLC | HWW | 2024-06-07 |
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| B504OMA39370 | Medartis | Provision | HWW | 2024-05-13 |
| B504OMA39380 | Medartis | Provision | HWW | 2024-05-13 |
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| 05055662969818 | COGNiTiON™ Staple System | ORTHO SOLUTIONS HOLDINGS LIMITED | HWW | 2024-04-01 |
| B504OMHSINK350 | TriMed | Provision | HWW | 2024-03-28 |
| 08800089445516 | Surgical Instrument | Jeil Medical Corporation | HWW | 2024-03-19 |
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