FDA UDI
In Commercial Distribution
🇺🇸 United States
CarboClear Hybrid Pedicle Screw System
DI: 07290117353745
·
Model: MIS Tab Remover
·
CARBOFIX ORTHOPEDICS LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CarboClear Hybrid Pedicle Screw System
- Primary DI
- 07290117353745
- Version / Model
- MIS Tab Remover
- Catalog Number
- HYB022
- Company Name
- CARBOFIX ORTHOPEDICS LTD
- Labeler DUNS
- 649185170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-15
- Public Version
- 2
- Public Version Date
- 2025-03-11
- Public Version Status
- Update
- Public Device Record Key
- fcbaaae9-9e1f-4dae-81ea-4fc6496be11b
Device Description
Instrument for removing Extended Tabs of MIS Hybrid Pedicle Screw
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
- No
- 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 |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
| PML | Bone Cement, Posterior Screw Augmentation | Orthopedic | 888.3027 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63105 | Orthopaedic instrument extractor | A hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290117353745 | GS1 |
Customer Contacts
- Phone
- +97299511511
- [email protected]
- Phone
- 1-800-408-0120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240846 | 000 |