FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrument Set (case and Reusable Instruments)
DI: 10855068008737
·
Model: CIS-004
·
Curvafix Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Instrument Set (case and Reusable Instruments)
- Primary DI
- 10855068008737
- Version / Model
- CIS-004
- Catalog Number
- CIS-004
- Company Name
- Curvafix Inc
- Labeler DUNS
- 039779098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-05
- Public Version
- 1
- Public Version Date
- 2023-01-13
- Public Version Status
- New
- Public Device Record Key
- c201b832-3da4-414c-9b11-a56d838c8984
Device Description
A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a CurvaFix surgical procedure.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44054 | Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10855068008737 | GS1 |
Customer Contacts
- Phone
- 425-276-8800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222505 | 000 |