ISSA™ mikro - ISSA™ mikro provides precise cleaning of baby - Foreo AB

Duns Number:352394143

Device Description: ISSA™ mikro provides precise cleaning of baby teeth by covering each tooth separately from ISSA™ mikro provides precise cleaning of baby teeth by covering each tooth separately from all angles, while gently massaging sensitive gums to soothe irritation. ISSA™ is intended for children 6 months through 4 years old.

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More Product Details

Catalog Number

-

Brand Name

ISSA™ mikro

Version/Model Number

PEARL PINK

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

76b808f0-a3a5-42d6-a0b3-aaaa5464754f

Public Version Date

June 03, 2022

Public Version Number

1

DI Record Publish Date

May 26, 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