AccessGUDID - DEVICE: PlasmaJet Neutral Plasma Surgery System (M397PS103130JP0)

GUDID

Device Identifier (DI) Information

Brand Name: PlasmaJet Neutral Plasma Surgery System
Version or Model: PS10-3130-JP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS10-3130-JP
Company Name: PLASMA SURGICAL, INC

Primary DI Number: M397PS103130JP0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 360799048 *Terms of Use

Device Description: PlasmaJet Ultra Plus Console System (Japan)

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:	No
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?
47273	Plasma surgical system	An assembly of electrically-powered devices designed to generate a fine plasma jet used to coagulate, cut, and/or vaporize/ablate tissue and/or reduce inflammation/promote healing during open, laparoscopic or topical surgery. The system has a gas [e.g., argon (Ar)] supply or an ambient air input, and typically includes a control unit, a handpiece(s) with connection cable and foot-switch. The plasma [e.g., argon (Ar), nitric oxide] is generated in the handpiece and is applied to tissue where the surgical effect is achieved without passing electric current through the body.	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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 2e36cb1c-328e-474a-b516-447ef3c8dde6
Public Version Date: June 08, 2021
Public Version Number: 2
DI Record Publish Date: October 02, 2018