I PLAY. INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ring, Teething, Fluid-Filled (KKO) (5) Ring, Teething, Non-Fluid Filled (MEF) (3) Pack, Hot Or Cold, Reusable (IME) (2)

Premarket Exempt

No Yes

Clear

Green Sprouts - 00715418088563 Catalog Number :

Device Description : Cool Calm Press-Pink-Adult use only

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418088648 Catalog Number :

Device Description : Everyday Teethers made from Silicone (2 pack)-Pink Set

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418088655 Catalog Number :

Device Description : Everyday Teethers made from Silicone (2 pack)-Blue Set

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418091136 Catalog Number : 222392

Device Description : Cooling Teether (2pk)-Pink Set Set-3mo+

Device Class :

Duns Number: 131904450

Premarket Exempt : No

Product Code : KKO

Prescription Use : No

Device Count : 2

Green Sprouts - 00715418091143 Catalog Number : 222392

Device Description : Cool Hand Teether 2pk-Boy's Set-3mo+

Device Class :

Duns Number: 131904450

Premarket Exempt : No

Product Code : KKO

Prescription Use : No

Device Count : 2

Green Sprouts - 00715418092843 Catalog Number :

Device Description : Everyday Teethers made from Silicone (2 pack)-Aqua Set

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418093314 Catalog Number :

Device Description : Cool Everyday Teethers (2pk)-Assorted-3mo+

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418094045 Catalog Number :

Device Description : Cool Calm Press-Assorted-Adult use only

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418095172 Catalog Number : 222340

Device Description : Cooling Teether-Purple Grape-3mo+

Device Class :

Duns Number: 131904450

Premarket Exempt : No

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418127620 Catalog Number :

Device Description : Teether Tower- Multicolor-6mo+

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

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