RAINTREE ESSIX 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

Mouthguard, prescription (MQC) (6)

Premarket Exempt

No Yes

Clear

Square ultrafit - D746UFS060X5S1 Catalog Number : UFS060X5S

Device Description : Square ultrafit sheets .060" 5-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 5

Round ultrafit - D746UFS080X25R1 Catalog Number : UFS080X25R

Device Description : Round ultrafit sheets .080"x125mm. 25-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 25

Square ultrafit - D746UFS080X50S1 Catalog Number : UFS080X50S

Device Description : Square ultrafit sheets .080" 50-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 50

Round ultrafit - D746UFS080X5R1 Catalog Number : UFS080X5R

Device Description : Round ultrafit sheets .080" 5-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 5

WHW DURAGUARD - D746WHWDGSC040BMS1 Catalog Number : WHWDGSC040BMS

Device Description : WHW DURAGUARD .040(1mm) BULK MEDIUM SQUARE

Device Class : U

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

WHW DURAGUARD - D746WHWDGSC060BMS1 Catalog Number : WHWDGSC060BMS

Device Description : WHW DURAGUARD .060(1.5mm) BULK MEDIUM SQUARE

Device Class : U

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

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