AccessGUDID - DEVICE: Canady Plasma GIT Side Fire Probe (B413AW4225410)

GUDID

Device Identifier (DI) Information

Brand Name: Canady Plasma GIT Side Fire Probe
Version or Model: AW-422541
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: US MEDICAL INNOVATIONS, LLC

Primary DI Number: B413AW4225410
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961656951 *Terms of Use

Device Description: The Canady Hybrid Plasma GIT probe is an electrosurgical plasma probe that is 2.3mm in diameter and 3.4m long. The electrosurgical plasma probe is used to 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?
61878	Inert gas-enhanced endoscopic electrosurgical electrode, single-use	An invasive, distal component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a single-use 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 [?]
K052035	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: 1b755d64-1792-43c4-9032-11883736429e
Public Version Date: April 04, 2023
Public Version Number: 3
DI Record Publish Date: March 05, 2018