AccessGUDID - DEVICE: Smilegoods Sonic Toothbrush White (00723896018729)

GUDID

Device Identifier (DI) Information

Brand Name: Smilegoods Sonic Toothbrush White
Version or Model: 7155010 WHI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7155010 WHI
Company Name: PRACTICON, INC.

Primary DI Number: 00723896018729
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Rechargable electric toothbrush with high density bristles. 1 Sonic handle, 2 brush heads, and charging base and cable. White color

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?
38581	Ionic electric toothbrush	A battery-powered instrument designed to brush clean the teeth and gums. It typically consists of a proximal handle and distal head to which is attached two or more rows of bristles (e.g., nylon) grouped in separate tufts, in rows, or evenly distributed; the head includes a light-activated semiconductor [e.g., a titanium (Ti) rod] that releases negative ions intended to disintegrate dental plaque. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing and is used with toothpaste; it is normally available [non-prescription] over-the-counter (OTC). The toothbrush head may be exchangeable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEQ	Toothbrush, Powered

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: 17c07b16-031e-4371-993e-6c41edadfd91
Public Version Date: June 19, 2023
Public Version Number: 1
DI Record Publish Date: June 09, 2023