AccessGUDID - DEVICE: ISSA™ 2 (07350092133623)

GUDID

Device Identifier (DI) Information

Brand Name: ISSA™ 2
Version or Model: COBALT BLUE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Foreo AB

Primary DI Number: 07350092133623
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 352394143 *Terms of Use

Device Description: ISSA™ 2 is a powered toothbrush that provides a comfortable gum massage and promotes excellent oral hygiene. The silicone and polymer cross-design is the hygienic choice, offering the highest level of clean with bristles that harbor less bacteria than conventional nylon.

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):	Yes
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?
43090	Basic electric toothbrush	An electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. 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: edd47bd5-9db8-4c33-bd3d-8bdd5803e80d
Public Version Date: June 03, 2022
Public Version Number: 1
DI Record Publish Date: May 26, 2022