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) (10)

Premarket Exempt

No Yes

Clear

Square ultrafit - D746UFS040X100SS1 Catalog Number : UFS040X100SS

Device Description : Square ultrafit sheets .040" 100-pack small

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 100

Round ultrafit - D746UFS040X10R1 Catalog Number : UFS040X10R

Device Description : Round ultrafit sheets .040"x125mm. 10-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 10

Square ultrafit - D746UFS040X10S1 Catalog Number : UFS040X10S

Device Description : Square ultrafit sheets .040". 10-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 10

Square ultrafit - D746UFS040X10SS1 Catalog Number : UFS040X10SS

Device Description : Square ultrafit sheets .040" 10-pack small

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 10

Round ultrafit - D746UFS060X25R1 Catalog Number : UFS060X25R

Device Description : Round ultrafit sheets .060"x125mm. 25-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 25

Square ultrafit - D746UFS060X25S1 Catalog Number : UFS060X25S

Device Description : Square ultrafit sheets .060" 25-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 25

Round ultrafit - D746UFS060X50R1 Catalog Number : UFS060X50R

Device Description : Round ultrafit sheets .060" 50-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 50

Square ultrafit - D746UFS060X50S1 Catalog Number : UFS060X50S

Device Description : Square ultrafit sheets .060" 50-pack

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 50

Square ultrafit - D746UFS060X50SS1 Catalog Number : UFS060X50SS

Device Description : Square ultrafit sheets .060" 50-pack small

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 50

Round ultrafit - D746UFS060X5R1 Catalog Number : UFS060X5R

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

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 5

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