FDA UDI
In Commercial Distribution
🇺🇸 United States
CarboClear Pedicle Screw System
DI: 07290109338903
·
Model: Guide Wire
·
CARBOFIX ORTHOPEDICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CarboClear Pedicle Screw System
- Primary DI
- 07290109338903
- Version / Model
- Guide Wire
- Catalog Number
- PPS922501
- Company Name
- CARBOFIX ORTHOPEDICS LTD
- Labeler DUNS
- 649185170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-24
- Public Version
- 7
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 9a3c9c9d-8246-4f9d-8861-0d44c5e97231
Device Description
Guide Wire for use with the CarboClear Pedicle Screw System.
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62729 | Orthopaedic guidewire, single-use | A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109338903 | GS1 | ||||
| Package | 17290109338900 | GS1 | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +97299511511
- [email protected]
- Phone
- 1-800-408-0120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173487 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 710 | Millimeter | |
| Outer Diameter | 1.2 | Millimeter |