Identity
- Trade Name
- Canady Hybrid Plasma Paddle Blade FDA UDI
- Generic Name
- Inert gas-enhanced open-surgery electrosurgical electrode, reusable FDA UDI
- Device Name
- The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm bendable paddle blade tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue. FDA UDI
- Model / Reference
- PB-422555 FDA UDI
- Description
- The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm bendable paddle blade tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B413PB4225550 FDA UDI
- 510(k) Number
- K113500 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Inert gas-enhanced open-surgery electrosurgical electrode, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Inert gas-enhanced open-surgery electrosurgical electrode, reusable
Canady Hybrid Plasma Paddle Blade by Us Medical Innovations, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inert gas-enhanced open-surgery electrosurgical electrode, reusable.
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm) — US MEDICAL INNOVATIONS, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Us Medical Innovations, Llc
Sources (1)
- FDA UDI 6e825663-7f43-447e-be16-997792b6633f 34 fields · synced May 31, 2026