Green Sprouts

FDA UDI

Class II (US FDA UDI)

by O2cool, LLC

Identity

Trade Name: Green Sprouts FDA UDI
Generic Name: Teething device, fluid-filled FDA UDI
Device Name: Cooling Teether-Clear-3mo+ FDA UDI
Model / Reference: 222341-920-33 FDA UDI
Description: Cooling Teether-Clear-3mo+ FDA UDI

Identifiers

Catalog Number: 222341 FDA UDI
Primary DI / UDI-DI: 00715418020358 FDA UDI
510(k) Number: K093370 FDA UDI
FDA Product Code: KKO FDA UDI
GMDN Term: Teething device, fluid-filled FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Teething device, fluid-filled

Green Sprouts by O2cool, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Sassy — SASSY BABY, INC · Class II

Cleared under the same submission

K093370 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: O2cool, LLC

Sources (1)

FDA UDI e596d768-8dab-4100-89e3-d376a178c4c3 35 fields · synced Jun 8, 2026