FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Canady Hybrid Plasma Scalpel
DI: B413AW4225520
·
Model: AW-422552
·
US MEDICAL INNOVATIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Canady Hybrid Plasma Scalpel
- Primary DI
- B413AW4225520
- Version / Model
- AW-422552
- Company Name
- US MEDICAL INNOVATIONS, LLC
- Labeler DUNS
- 961656951
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-05
- Public Version
- 4
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 1093597a-c34f-4212-9bd9-d4dc5b2fa5ae
- Distribution End Date
- 2020-03-23
Device Description
The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 35mm non-bendable tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological 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 | B413AW4225520 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113500 | 000 |