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) (4) Pack, Hot Or Cold, Reusable (IME) (2) Ring, Teething, Non-Fluid Filled (MEF) (2) Apparatus, Suction, Single Patient Use, Portable, Nonpowered (GCY) (1) Toothbrush, Manual (EFW) (1)

Premarket Exempt

No Yes

Clear

Green Sprouts - 00715418020341 Catalog Number :

Device Description : Cool Fruit Teether-Assorted-3mo+

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418020358 Catalog Number : 222341

Device Description : Cooling Teether-Clear-3mo+

Device Class : 2

Duns Number: 131904450

Premarket Exempt : No

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418022956 Catalog Number :

Device Description : First Toothbrush made from Silicone-Clear

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : EFW

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418028590 Catalog Number :

Device Class : 2

Duns Number: 131904450

Premarket Exempt : No

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418028606 Catalog Number :

Device Description : Cool Fruit Teether-Green Apple-3mo+

Device Class : 2

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : KKO

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418046464 Catalog Number :

Device Description : Nasal Aspirator-Green-Adult use only

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : GCY

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418071640 Catalog Number :

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

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418071657 Catalog Number :

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

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418077291 Catalog Number :

Device Description : Teething Keys-Multicolor-3mo+

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

Green Sprouts - 00715418088495 Catalog Number :

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

Device Class : 1

Duns Number: 131904450

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

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