FDA UDI
In Commercial Distribution
🇺🇸 United States
FuzeFix Chamfered Screws
DI: 00840124514201
·
Model: TN-CS-8055
·
FUSION ORTHOPEDICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- FuzeFix Chamfered Screws
- Primary DI
- 00840124514201
- Version / Model
- TN-CS-8055
- Catalog Number
- TN-CS-8055
- Company Name
- FUSION ORTHOPEDICS, LLC
- Labeler DUNS
- 080307067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-28
- Public Version
- 1
- Public Version Date
- 2024-11-05
- Public Version Status
- New
- Public Device Record Key
- 54215dde-8398-44c1-aea9-9bece110f24c
Device Description
Manual Rasp Mirror
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QBO | Instruments Designed For Press-Fit Osteochondral Implants | Orthopedic | 888.4505 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64557 | Orthopaedic fixation plate file/rasp | A hand-held manual instrument designed to blunt and smooth the sharp edges of an orthopaedic fixation plate that has been cut by the surgeon during orthopaedic surgery. It is made of metal materials and is in the form of a rod with an abrasive working end, typically coated with diamond particles. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840124514201 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170038 | 000 |