FDA UDI
In Commercial Distribution
🇺🇸 United States
Countersink
DI: 10855068008218
·
Model: CCB-001
·
Curvafix Inc
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Countersink
- Primary DI
- 10855068008218
- Version / Model
- CCB-001
- Catalog Number
- CCB-001
- Company Name
- Curvafix Inc
- Labeler DUNS
- 039779098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-11
- Public Version
- 2
- Public Version Date
- 2023-08-01
- Public Version Status
- Update
- Public Device Record Key
- 69854c31-ada4-4e1c-8155-fa8a164b49e9
Device Description
A manual rotary tool used to enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWW | Countersink | Orthopedic | 888.4540 | 1 |
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16462 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10855068008218 | GS1 |
Customer Contacts
- Phone
- 425-276-8800
- [email protected]