FDA UDI
In Commercial Distribution
🇺🇸 United States
Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm)
DI: B413CP411100
·
Model: CP-41110
·
US MEDICAL INNOVATIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm)
- Primary DI
- B413CP411100
- Version / Model
- CP-41110
- Company Name
- US MEDICAL INNOVATIONS, LLC
- Labeler DUNS
- 961656951
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-09
- Public Version
- 1
- Public Version Date
- 2024-05-17
- Public Version Status
- New
- Public Device Record Key
- 570c5add-3db3-4731-b176-e84e55fcbdf4
Device Description
The Canady Helios Cold Plasma Ablator Handpies (85mm) is an electrosurgical plasma application device that uses and 85mm tip. The device is used to ablate soft tissue.
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 61879 | Inert gas-enhanced open-surgery electrosurgical electrode, reusable | A rigid, invasive, distal component of an inert gas-enhanced electrosurgical system intended to be connected to a handpiece (not included) to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation during open surgery. It is typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery sleeve; it requires a patient contact return electrode to complete the circuit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B413CP411100 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240297 | 000 |