AccessGUDID - DEVICE: PlasmaJet Neutral Plasma Surgery System (M397S2CDU70)

GUDID

Device Identifier (DI) Information

Brand Name: PlasmaJet Neutral Plasma Surgery System
Version or Model: S2-CDU-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S2-CDU-7
Company Name: PLASMA SURGICAL, INC

Primary DI Number: M397S2CDU70
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 360799048 *Terms of Use

Device Description: Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System

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?
47275	Plasma surgical system handpiece	A hand-held instrument used with a plasma surgical system control unit to coagulate, cut, and/or vaporize/ablate tissue during open and/or laparoscopic surgery. Inert argon (Ar) gas is excited (ionized) in the instrument by a series of internal bipolar electrodes to generate plasma (atomic ions and free electrons) which emerges from the tip of the handpiece in a stream to release kinetic and thermal energy upon contact with tissue. Operation is regulated using a hand-control on the instrument or via a connected foot-switch. The instrument is typically in the form of a pen/pencil with attached cables for connection to the control unit. 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 [?]
K121977	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7 Centimeter

Device Record Status

Public Device Record Key: a8319050-9e93-4820-b02d-58170cd0ab98
Public Version Date: September 15, 2023
Public Version Number: 1
DI Record Publish Date: September 07, 2023