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ISSA™ play

FDA UDI

Class I (US FDA UDI)

by Foreo Inc

Identity

Trade Name
ISSA™ play FDA UDI
Generic Name
Basic electric toothbrush FDA UDI
Device Name
ISSA™ play is a powered toothbrush that is specifically engineered to utilize soft silicone bristles for the gum area, the ISSA™ play also integrates PBT polymer bristles with hygienic properties superior to standard nylon bristles. This dynamic cross-design is designed to target plaque buildup for a clean that’s sure to put a smile on your face. FDA UDI
Model / Reference
COOL BLACK FDA UDI
Description
ISSA™ play is a powered toothbrush that is specifically engineered to utilize soft silicone bristles for the gum area, the ISSA™ play also integrates PBT polymer bristles with hygienic properties superior to standard nylon bristles. This dynamic cross-design is designed to target plaque buildup for a clean that’s sure to put a smile on your face. FDA UDI

Identifiers

Primary DI / UDI-DI
07350092135191 FDA UDI
FDA Product Code
JEQ FDA UDI
GMDN Term
Basic electric toothbrush FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6865 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Basic electric toothbrush

ISSA™ play by Foreo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic electric toothbrush.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Foreo Inc

Sources (1)

  • FDA UDI 204af939-d5c0-4da2-90be-950bcee9ca4a 33 fields · synced May 30, 2026