AccessGUDID - DEVICE: MIRARI Cold Plasma Driver (00860013508616)

GUDID

Device Identifier (DI) Information

Brand Name: MIRARI Cold Plasma Driver
Version or Model: GVM2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: General Vibronics, LLC

Primary DI Number: 00860013508616
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020484227 *Terms of Use

Device Description: No description.

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?
47576	Medium-wave diathermy treatment system generator	A component of a medium-wave diathermy treatment system that generates electromagnetic (EM) energy, in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz, applied transcutaneously to provide a deep heat within specific volumes of a patient's body. The energy generated by this device is typically conducted through a hand-operated electrode moved across the treatment area to treat pain, muscle spasms, and joint contractures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBX	Massager, Vacuum, Radio Frequency Induced Heat
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242553	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: e7b47c23-fa49-43b6-bb23-709fc98cd1d6
Public Version Date: May 08, 2025
Public Version Number: 1
DI Record Publish Date: April 30, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES