AccessGUDID - DEVICE: HERAGATA-ARROW SHAPE SHONISHIN (14897076721099)

GUDID

Device Identifier (DI) Information

Brand Name: HERAGATA-ARROW SHAPE SHONISHIN
Version or Model: Shoni.Hera
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TENS PLUS INDUSTRIAL COMPANY

Primary DI Number: 14897076721099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 663211978 *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):	No
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?
45168	Static magnetic massager	A hand-held device designed to be moved over body surfaces that uses static magnets (e.g., rotating magnetic balls) intended to produce a weak magnetic flux over a superficial body site to provide comfort and localized temporary relief from minor aches and pains. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYG	Massager, Therapeutic, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 64c6ed86-1be1-4772-86df-43debbe658c5
Public Version Date: November 22, 2022
Public Version Number: 1
DI Record Publish Date: November 14, 2022