AccessGUDID - DEVICE: Canady Hybrid Plasma Scalpel (B413AW4225540)

GUDID

Device Identifier (DI) Information

Brand Name: Canady Hybrid Plasma Scalpel
Version or Model: AW-422554
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: US MEDICAL INNOVATIONS, LLC

Primary DI Number: B413AW4225540
Issuing Agency: HIBCC
Commercial Distribution End Date: March 23, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 961656951 *Terms of Use

Device Description: The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm non-bendable tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113500	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d33219bf-4f75-4801-b4f4-b3c9360ca088
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: March 05, 2018