FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaway
DI: 06936666559405
·
Model: CFC 2.0-7-100
·
Zhejiang CuraWay Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Curaway
- Primary DI
- 06936666559405
- Version / Model
- CFC 2.0-7-100
- Company Name
- Zhejiang CuraWay Medical Technology Co., Ltd.
- Labeler DUNS
- 412923111
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 1
- Public Version Date
- 2025-09-09
- Public Version Status
- New
- Public Device Record Key
- a4bd7d53-9fa4-418f-8933-6b5a949568d1
Device Description
Endovenous Radiofrequency Catheter
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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62233 | Peripheral vascular electrocautery catheter, single-use | A flexible catheter with a distal heating element/electrode intended to be connected to an electrical generator and introduced into the peripheral vasculature to ablate venous tissues, through direct application of heat, as a treatment for venous reflux disease (varicose veins); it is not intended to introduce electrical current into the body. It is a luminal device with a proximal handle with controls (e.g., on/off switch) that is introduced via an introducer assembly (which may be included), and is typically maneuvered under external image guidance [e.g., ultrasound (US)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16936666559402 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 06936666559405 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232505 | 000 |