ISSA™ 3 - ISSA™ 3 is a powered toothbrush with ultra-soft - Foreo AB

Duns Number:352394143

Device Description: ISSA™ 3 is a powered toothbrush with ultra-soft medical-grade silicone and PBT polymer bri ISSA™ 3 is a powered toothbrush with ultra-soft medical-grade silicone and PBT polymer bristles that remove plaque, and gently massages gums, while the tongue and cheek cleaner on the back helps improve overall oral health.

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More Product Details

Catalog Number

-

Brand Name

ISSA™ 3

Version/Model Number

MINT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JEQ

Product Code Name

Toothbrush, Powered

Device Record Status

Public Device Record Key

d4243322-1f5a-4ee0-8d86-26a8979d0161

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FOREO AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 7